Assessing olpasiran treatment for heart disease and elevated cholesterol

Recruting new patients

Select region:

Navigation:

    What is this study about?

    Tests named ‘OCEAN(a)’ are being conducted, focusing on a medication called ‘olpasiran’. Put simply, the potential of this medication in preventing serious heart episodes in individuals with Atherosclerotic Cardiovascular Disease and an elevated level of a fat protein, Lipoprotein(a), is under examination. The effect of a harmless, dummy pill (placebo) is compared to that of the actual medication, olpasiran, in individuals with these conditions. The primary goal is to determine whether olpasiran can reduce the risk of death due to heart disease, occurrence of heart attacks, or the necessity for sudden surgery to clear blocked heart vessels.

    Learn more about this Trial

      I accept the Terms of Use and Privacy Policy*

       I consent to the Service Operator sending commercial information*

      I consent to the Service Operator using telecommunications terminal devices and automatic calling systems in marketing communications*

      Success

      Your form submitted successfully!

      Error

      Sorry! your form was not submitted properly, Please check the errors above.

      Locations

      Where does the clinical trial take place?

      Feldkirch , Austria

      Graz , Austria

      Klagenfurt , Austria

      Linz , Austria

      Salzburg , Austria

      Sankt Poelten , Austria

      Wien , Austria

      Wien , Austria

      Wien , Austria

      Wien , Austria

      Wien , Austria

      Aalst , Belgium

      Aalst , Belgium

      Antwerpen , Belgium

      Brussels , Belgium

      Dendermonde , Belgium

      Edegem , Belgium

      Genk , Belgium

      Gent , Belgium

      Hasselt , Belgium

      Leuven , Belgium

      Liu00e8ge , Belgium

      Mechelen , Belgium

      Turnhout , Belgium

      Blagoevgrad , Bulgaria

      Haskovo , Bulgaria

      Pleven , Bulgaria

      Pleven , Bulgaria

      Sliven , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Stara Zagora , Bulgaria

      Varna , Bulgaria

      Beroun , Czechia

      Bilina , Czechia

      Brandys nad Labem , Czechia

      Brno , Czechia

      Brno , Czechia

      Brno , Czechia

      Brno , Czechia

      Brno , Czechia

      Ceske Budejovice , Czechia

      Chomutov , Czechia

      Havirov – Mesto , Czechia

      Holesov , Czechia

      Hradec Kralove , Czechia

      Hradec Kralove , Czechia

      Jihlava , Czechia

      Klatovy IV , Czechia

      Nachod , Czechia

      Olomouc , Czechia

      Ostrava – Moravska Ostrava , Czechia

      Ostrava-Dubina , Czechia

      Ostrava , Czechia

      Pardubice , Czechia

      Plzen , Czechia

      Policka , Czechia

      Praha 10 , Czechia

      Praha 2 , Czechia

      Praha 4 , Czechia

      Praha 4 , Czechia

      Praha 5 – Smichov , Czechia

      Praha 5 , Czechia

      Praha 9 , Czechia

      Prerov , Czechia

      Pribram VIII , Czechia

      Trutnov , Czechia

      Uherske Hradiste , Czechia

      Zlin , Czechia

      Zlin , Czechia

      Aalborg , Denmark

      Aarhus N , Denmark

      Copenhagen O , Denmark

      Esbjerg , Denmark

      Gandrup , Denmark

      Herlev , Denmark

      Herlev , Denmark

      Herning , Denmark

      Holbaek , Denmark

      Kobenhavn NV , Denmark

      Kobenhavn S , Denmark

      Roskilde , Denmark

      Slagelse , Denmark

      Svendborg , Denmark

      Vejle , Denmark

      Viborg , Denmark

      Helsinki , Finland

      Kuopio , Finland

      Oulu , Finland

      Tampere , Finland

      Turku , Finland

      Besancon cedex , France

      Bron cedex , France

      Chambray les Tours , France

      Compiegne , France

      Dijon , France

      Lille Cedex , France

      Marseille Cedex 08 , France

      Marseille , France

      Montpellier cedex 05 , France

      Nantes Cedex 1 , France

      Nice Cedex 1 , France

      Paris Cedex 13 , France

      Paris Cedex 18 , France

      Paris , France

      Reims , France

      Rennes , France

      Strasbourg , France

      Toulouse Cedex 9 , France

      Valenciennes , France

      Aachen , Germany

      Bad Krozingen , Germany

      Bad Oeynhausen , Germany

      Berlin , Germany

      Berlin , Germany

      Berlin , Germany

      Bremen , Germany

      Dresden , Germany

      Essen , Germany

      Frankfurt am Main , Germany

      Frankfurt am Main , Germany

      Goettingen , Germany

      Goettingen , Germany

      Hamburg , Germany

      Hamburg , Germany

      Heidelberg , Germany

      Kassel , Germany

      Koeln , Germany

      Leipzig , Germany

      Magdeburg , Germany

      Mannheim , Germany

      Markkleeberg , Germany

      Muenchen , Germany

      Muenster , Germany

      Papenburg , Germany

      Remscheid , Germany

      Rostock , Germany

      Ruedersdorf , Germany

      Singen , Germany

      Witten , Germany

      Athens , Greece

      Athens , Greece

      Athens , Greece

      Athens , Greece

      Athens , Greece

      Athens , Greece

      Athens , Greece

      Athens , Greece

      Athens , Greece

      Heraklion , Greece

      Ioannina , Greece

      Mitilini , Greece

      Thessaloniki , Greece

      Baja , Hungary

      Bekescsaba , Hungary

      Budapest , Hungary

      Budapest , Hungary

      Budapest , Hungary

      Budapest , Hungary

      Budapest , Hungary

      Budapest , Hungary

      Debrecen , Hungary

      Gyongyos , Hungary

      Hatvan , Hungary

      Komarom , Hungary

      Miskolc , Hungary

      Oroshaza , Hungary

      Szekesfehervar , Hungary

      Zalaegerszeg , Hungary

      Zalaegerszeg , Hungary

      Arzignano , Italy

      Bologna , Italy

      Brescia , Italy

      Caserta , Italy

      Catania , Italy

      Catanzaro , Italy

      Cona FE , Italy

      Firenze , Italy

      Genova , Italy

      Milano , Italy

      Milano , Italy

      Napoli , Italy

      Palermo , Italy

      Rivoli , Italy

      Roma , Italy

      Roma , Italy

      Rozzano MI , Italy

      Salerno , Italy

      Sesto San Giovanni (MI) , Italy

      Torino , Italy

      Amersfoort , Netherlands

      Amsterdam , Netherlands

      Amsterdam , Netherlands

      Apeldoorn , Netherlands

      Arnhem , Netherlands

      Bergen op Zoom , Netherlands

      Breda , Netherlands

      Delft , Netherlands

      Den Haag , Netherlands

      Deventer , Netherlands

      Eindhoven , Netherlands

      Eindhoven , Netherlands

      Enschede , Netherlands

      Goes , Netherlands

      Gouda , Netherlands

      Groningen , Netherlands

      Heerlen , Netherlands

      Hoofddorp , Netherlands

      Hoorn , Netherlands

      Leiden , Netherlands

      Leiderdorp , Netherlands

      Nijmegen , Netherlands

      Rotterdam , Netherlands

      Sneek , Netherlands

      The Hague , Netherlands

      Tiel , Netherlands

      Tilburg , Netherlands

      Utrecht , Netherlands

      Venlo , Netherlands

      Oslo , Norway

      Oslo , Norway

      Skedsmokorset , Norway

      Belchatow , Poland

      Bielsko-Biala , Poland

      Chrzanow , Poland

      Dabrowa Gornicza , Poland

      Gdansk , Poland

      Gizycko , Poland

      Kedzierzyn Kozle , Poland

      Krakow , Poland

      Lodz , Poland

      Lubin , Poland

      Lublin , Poland

      Lublin , Poland

      Lublin , Poland

      Poznan , Poland

      Pulawy , Poland

      Sztum , Poland

      Tychy , Poland

      Warszawa , Poland

      Warszawa , Poland

      Warszawa , Poland

      Wroclaw , Poland

      Zabrze , Poland

      Zamosc , Poland

      Zgierz , Poland

      Almada , Portugal

      Amadora , Portugal

      Aveiro , Portugal

      Braga , Portugal

      Carnaxide , Portugal

      Cascais , Portugal

      Coimbra , Portugal

      Guimaraes , Portugal

      Matosinhos , Portugal

      Porto , Portugal

      Santa Maria da Feira , Portugal

      Setubal , Portugal

      Vila Nova de Gaia , Portugal

      Baia Mare , Romania

      Bucharest , Romania

      Bucuresti , Romania

      Buzau , Romania

      Pitesti , Romania

      Targu Mures , Romania

      Targu-Mures , Romania

      Timisoara , Romania

      Bardejov , Slovakia

      Bratislava , Slovakia

      Bratislava , Slovakia

      Brezno , Slovakia

      Klastor pod Znievom , Slovakia

      Kosice , Slovakia

      Kosice , Slovakia

      Kosice , Slovakia

      Lucenec , Slovakia

      Moldava nad Bodvou , Slovakia

      Namestovo , Slovakia

      Nitra , Slovakia

      Nove Zamky , Slovakia

      Presov , Slovakia

      Presov , Slovakia

      Rimavska Sobota , Slovakia

      Roznava , Slovakia

      Svidnik , Slovakia

      Trebisov , Slovakia

      Trencin , Slovakia

      Cordoba , Spain

      Malaga , Spain

      Sevilla , Spain

      Sevilla , Spain

      Zaragoza , Spain

      Gijon , Spain

      Leon , Spain

      Badalona , Spain

      Barcelona , Spain

      Barcelona , Spain

      Barcelona , Spain

      Barcelona , Spain

      Hospitalet de Llobregat , Spain

      Sant Joan Despi , Spain

      Valencia , Spain

      Valencia , Spain

      A Coruu00f1a , Spain

      Vigo , Spain

      El Palmar , Spain

      Madrid , Spain

      Madrid , Spain

      Madrid , Spain

      Falun , Sweden

      Gu00f6teborg , Sweden

      Helsingborg , Sweden

      Lund , Sweden

      Malmo , Sweden

      Stockholm , Sweden

      Stockholm , Sweden

      Belfast , United Kingdom

      Birmingham , United Kingdom

      Blackpool , United Kingdom

      Bradford , United Kingdom

      Bristol , United Kingdom

      Chichester , United Kingdom

      Chippenham , United Kingdom

      Craigavon , United Kingdom

      Enfield , United Kingdom

      Exeter , United Kingdom

      Glasgow , United Kingdom

      Harefield , United Kingdom

      High Wycombe , United Kingdom

      Inverness , United Kingdom

      Leicester , United Kingdom

      Lincoln , United Kingdom

      London , United Kingdom

      London , United Kingdom

      Penarth , United Kingdom

      Poole , United Kingdom

      Preston , United Kingdom

      Stevenage , United Kingdom

      You can join this study in:

      Germany: Aachen, Bad Krozingen, Bad Oeynhausen, Berlin, Bremen, Dresden, Essen, Hamburg, Heidelberg, Kassel, Leipzig, Magdeburg, Mannheim, Markkleeberg, Papenburg, Remscheid, Rostock, Rüdersdorf, Singen, Witten.

      Denmark: Aalborg, Esbjerg, Gandrup, Herlev, Herning, Holbæk, Roskilde, Slagelse, Svendborg, Vejle, Viborg.

      Belgium: Aalst, Brussels, Dendermonde, Edegem, Genk, Hasselt, Leuven, Mechelen, Turnhout.

      Portugal: Almada, Amadora, Aveiro, Braga, Carnaxide, Cascais, Coimbra, Guimarães, Matosinhos, Porto, Santa Maria da Feira, Setúbal, Vila Nova de Gaia.

      Netherlands: Amersfoort, Amsterdam, Apeldoorn, Arnhem, Bergen op Zoom, Breda, Delft, Deventer, Eindhoven, Enschede, Goes, Gouda, Groningen, Heerlen, Hoofddorp, Hoorn, Leiden, Leiderdorp, Nijmegen, Rotterdam, Sneek, The Hague, Tiel, Tilburg, Utrecht, Venlo.

      Italy: Arzignano, Bologna, Brescia, Caserta, Catania, Catanzaro, Palermo, Rivoli, Salerno.

      Spain: Badalona, Barcelona, Córdoba, Gijón, León, Madrid, Sant Joan Despí, Saragossa, Vigo.

      Romania: Baia Mare, Bucharest, Buzău, Pitești.

      Hungary: Baja, Budapest, Debrecen, Hatvan, Komárom, Miskolc, Orosháza, Székesfehérvár, Zalaegerszeg.

      Slovakia: Bardejov, Bratislava, Brezno, Kláštor pod Znievom, Lučenec, Moldava nad Bodvou, Námestovo, Nitra, Nové Zámky, Rimavská Sobota, Rožňava, Svidník.

      Poland: Bełchatów, Bielsko-Biała, Chrzanów, Dąbrowa Górnicza, Gdańsk, Giżycko, Kędzierzyn Koźle, Łódź, Lubin, Lublin, Poznań, Sztum, Tychy, Wrocław, Zabrze, Zamość, Zgierz.

      United Kingdom: Belfast, Birmingham, Blackpool, Bradford, Bristol, Chichester, Chippenham, Craigavon, Exeter, Glasgow, Harefield, High Wycombe, Inverness, Leicester, Lincoln, London, Penarth, Poole, Preston, Stevenage.

      Czechia: Beroun, Bílina, Brno, Chomutov, Holešov, Hradec Králové, Jihlava, Olomouc, Ostrava, Pardubice, Polička, Trutnov, Zlín.

      Bulgaria: Blagoevgrad, Haskovo, Pleven, Sliven, Sofia, Stara Zagora, Varna.

      France: Compiègne, Dijon, Marseille, Paris, Reims, Rennes, Strasbourg, Valenciennes.

      Sweden: Falun, Helsingborg, Lund, Malmö, Stockholm.

      Austria: Feldkirch, Graz, Linz, Salzburg.

      Finland: Helsinki, Kuopio, Oulu, Tampere, Turku.

      Greece: Heraklion, Ioannina, Mytilene, Thessaloniki.

      Norway: Oslo, Skedsmokorset.


      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      In this clinical trial, there are two steps that a patient can be assigned to, based on the treatment group they are randomized into:

      1. Placebo Group: Patients receive a placebo administered by subcutaneous injection.
      2. Olpasiran Group: Patients are administered Olpasiran, an experimental drug, by subcutaneous injection.

      In both cases, the administration is via subcutaneous injection, and the exact frequency or duration is not specified here. For more detailed information, we would need to look further into the provided document or additional study protocol materials.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the study, you need to have a history of atherosclerotic cardiovascular disease (ASCVD). This can be evidenced by a history of either:

      1. Myocardial infarction (presumed type 1 event due to plaque rupture/erosion)
      2. Coronary revascularization with percutaneous coronary intervention

      Additionally, there should be at least one more risk factor present.


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      To join the study, you must meet the following inclusion criteria:

      1. Age: You must be between 18 to 85 years old.
      2. Lp(a) Level: You must have a Lipoprotein(a) level of at least 200 nmol/L during the screening phase. Lipoprotein(a), abbreviated as Lp(a), is a type of low-density lipoprotein (LDL) that carries cholesterol in the blood and is associated with a higher risk of cardiovascular diseases.
      3. History of ASCVD: You must have a history of atherosclerotic cardiovascular disease (ASCVD), which is a condition characterized by the build-up of fats, cholesterol, and other substances in and on the artery walls, leading to cardiovascular disease. Specifically, this includes having had either:
        • Myocardial infarction, which is a presumed type 1 event due to plaque rupture/erosion, commonly known as a heart attack.
        • Coronary revascularization with percutaneous coronary intervention, which is a nonsurgical procedure that improves blood flow to the heart.

        In addition, you must have at least 1 additional risk factor for cardiovascular disease (the specific risk factor is not mentioned, but this can typically include things like high blood pressure, diabetes, obesity, smoking, or a family history of heart disease).

      These conditions aim to select participants who have an increased risk of heart-related health issues and may potentially benefit from the medication being studied, while also ensuring their previous medical history and current health status allow for safe participation in the trial.

      What Reasons Could Exclude Me from the Study?

      Exclusion Criteria: The following conditions may prevent you from participating in the study:

      1. Severe renal dysfunction: This means that the kidneys are not working well enough to perform their functions, which includes filtering waste products from the blood.
      2. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN), or total bilirubin (TBL) > 2 x ULN during screening: These are liver enzymes, and their high levels in your blood may indicate liver damage. ULN refers to the highest level of the enzyme that is considered normal for most people.
      3. History of hemorrhagic stroke: This is a type of stroke that occurs when a blood vessel in the brain breaks open, causing bleeding inside the brain.
      4. History of major bleeding disorder: Such disorders result in a person bleeding easily and excessively due to problems with blood clotting.
      5. Planned cardiac surgery or arterial revascularization: This means upcoming procedures to correct heart or artery problems.
      6. Severe heart failure: A condition in which the heart muscle is weakened and cannot pump blood effectively to meet the body’s needs.
      7. Current, recent, or planned lipoprotein apheresis: A treatment that removes LDL cholesterol and other substances from your blood.
      8. Previously received ribonucleic acid (RNA) therapy specifically targeting Lp(a): If you have previously been treated with RNA therapy that targets lipoprotein(a) specifically, you would be excluded from this trial.

      These criteria ensure the safety of participants and the integrity of the study results.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The drugs involved in the study are:

      1. Placebo: A substance with no active therapeutic effect, used as a control in experiments to test the efficacy of another substance (active substance not applicable).
      2. Olpasiran: A medication used for therapeutic purposes. However, no additional details regarding the active substance of Olpasiran are provided in the given document. To provide a brief description of Olpasiran, I would need to conduct further research outside the given file, but as per my current capabilities, internet access is disabled.

      If you have any more specific questions or need further information that might be available in the study document, please let me know.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The active substances participating in the clinical trial are:

      1. Placebo: This is not an active substance but is used as a control in clinical trials. In this study, a placebo is given by subcutaneous injection once every 12 weeks (Q12W). Placebos are commonly known in medicine and medical literature and are used to ensure that the effects seen in the study are truly due to the drug being tested and not other factors.
      2. Olpasiran: Olpasiran is the experimental drug in this study. It is also administered via subcutaneous injection every 12 weeks. Olpasiran is being studied for its effects on cardiovascular events in participants with atherosclerotic cardiovascular disease and elevated Lipoprotein(a).

      Since Olpasiran (also known as AMG 890) is in a phase 3 clinical trial, it is considered an investigational new drug and may not be widely known or available in the market yet. It is introduced to evaluate its efficacy and safety in reducing the risk for coronary heart disease death, myocardial infarction, or urgent coronary revascularization in participants meeting certain criteria. This indicates that while it may be known to some extent in medical literature, it is not a standard or widely used treatment currently.


      Study ID

      CT-EU-00041960

      Recruitment status

      Recruting new patients

      Start of the trial

      2 years ago

      Study phase

      Phase
      III

      Medicinal Product

      Diseases