Study of Olpasiran to prevent first major cardiovascular events in people with high levels of lipoprotein(a)

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What is this study about?

This study focuses on people with Cardiovascular Disease who have elevated levels of lipoprotein(a), a substance in the blood that can increase the risk of heart problems. The research examines a medication called olpasiran to determine if it can help prevent first-time major heart events in people who have never experienced them before.

The study tests whether olpasiran is more effective than a placebo in reducing the risk of serious heart-related events. These events include coronary heart disease death, myocardial infarction (heart attack), and emergency procedures to restore blood flow to the heart. The medication is being studied specifically in people who have high levels of lipoprotein(a) in their blood and are considered at risk for heart problems.

During the study, participants will receive either olpasiran or a placebo while continuing their usual heart medications. The study will track any heart-related events that occur and measure how the treatment affects the amount of lipoprotein(a) in the blood. This research is part of a larger program called OCEAN(a)-PreEvent, which aims to better understand how to prevent first-time heart problems in people with high lipoprotein(a) levels.

1 Initial assessment

Your lipoprotein(a) levels will be measured through a blood test at a central laboratory

The test will confirm if your levels are ≥ 200 nmol/L, which is required for participation

Your current heart health and risk factors for heart disease will be evaluated

2 Random group assignment

You will be randomly assigned to receive either olpasiran (the study medication) or a placebo (inactive substance)

Neither you nor your doctor will know which treatment you are receiving during the study

3 Treatment period

The study will continue until 2031

You will maintain your current heart medications throughout the study

Your lipoprotein(a) levels will be measured regularly, including a specific check at week 48

Regular health assessments will monitor for any heart-related events

4 Health monitoring

Your heart health will be closely monitored for events such as:

– Heart attacks

– Need for urgent heart procedures

– Stroke

– Any heart-related complications

5 Study completion

The study will end in February 2031

Final health assessments will be conducted

Your doctor will discuss follow-up care options with you

Who Can Join the Study?

  • Must be able to provide written informed consent (agreement to participate) before any study procedures begin
  • Must be 50 years or older at the time of signing the screening consent form
  • Must have a lipoprotein(a) level of 200 nmol/L or higher (a type of blood fat that will be measured during screening)
  • Must be on stable lipid-lowering therapy (medications that help control blood fats) for at least 4 weeks before screening
  • Must meet at least one of these conditions:
    • Have multiple risk factors for heart and blood vessel disease
    • OR have a history of atherosclerosis (buildup of plaque in arteries)
  • Both men and women can participate in the study

Who Cannot Join the Study?

  • History of heart attack (myocardial infarction) or coronary revascularization (heart procedure to restore blood flow)
  • Currently taking medications that significantly affect blood lipids (fat-like substances in blood)
  • Severe kidney disease or currently on dialysis (blood filtering treatment)
  • Uncontrolled high blood pressure (blood pressure consistently above 160/100)
  • History of bleeding disorders or significant bleeding events in the past 6 months
  • Active liver disease or abnormal liver function tests
  • Current participation in other clinical trials or within past 30 days
  • Known allergic reactions to similar medications
  • Pregnant women or those planning pregnancy during the study period
  • History of substance abuse within the past year
  • Any condition that, in the opinion of study doctors, would make participation unsafe
  • Unable to provide informed consent or follow study procedures

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA Rome Italy
Medical University Of Vienna Vienna Austria
University Hospital Jena KöR Jena Germany
Sydvestjysk Sygehus Esbjerg Denmark
Centre Hospitalier Universitaire De Lille Lille France
Centro Hospitalar Universitario Sao Joao E.P.E. Porto Portugal
Medizinische Universitaet Innsbruck Innsbruck Austria
Azienda Ospedaliero Universitaria Careggi Florence Italy
Technische Universitaet Dresden Dresden Germany
Katholieke Universiteit te Leuven Leuven Belgium
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Unidade Local De Saude De Lisboa Ocidental E.P.E. Carnaxide Portugal
CHU Grenoble Alpes La Tronche France
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium
Ente Ecclesiastico Ospedale Generale Regionale Miulli Acquaviva Delle Fonti Italy
Gemeinschaftspraxis Dres. Holger Kittner und Kerstin Hartig Naunhof Germany
Pentes s.r.o. Zilina Slovakia
Gabinet lekarski Maciej Karcz Warsaw Poland
Ostin s.r.o. Ostrava Czechia
Top Moravia Health s.r.o. Brno Czechia
Geomedical Kft. Budapest Hungary
4 Wojskowy SzpitaKliniczny Z Polikliniką Samodzielny Publiczny ZakładOpieki ZdrowotneWe Wrocławiu Wroclaw Poland
Universitaetsmedizin Goettingen Goettingen Germany
Synexus Polska Sp. z o.o. Poznan Poland
Ctc Hodonín s.r.o. Hodonin Czechia
Oralek s.r.o. Namestovo Slovakia
Zuyderland Medisch Centrum Stichting Geleen The Netherlands
Azienda Ospedaliero Universitaria Di Sassari Sassari Italy
Imed19 Betriebs GmbH Vienna Austria
Centre Hospitalier De Beziers Beziers France
Frisius Heerenveen The Netherlands
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Medical University Of Graz Graz Austria
Trial Pharma Kft. Gyula Hungary
Futuremeds Sp. z o.o. Wroclaw Poland
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Diagnostic & Therapeutic Center Of Athens Hygeia Single Member S.A. Athens Greece
Spitalul Universitar De Urgenta Bucuresti Bucharest Romania
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Diagnostic Consultation Center XX-Sofia EOOD Sofia Bulgaria
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Az Maria Middelares Gent Gent Belgium
Interna SK s.r.o. Svidnik Slovakia
Otto Von Guericke Universitaet Magdeburg Magdeburg Germany
Coromed-Smo Kft. Pecs Hungary
Centre Hospitalier De Tourcoing Tourcoing France
Klinikum Coburg GmbH Coburg Germany
Clinexpert Kft. Budapest Hungary
MUDr. Libor Nechvatal s.r.o. Brno-Stred Czechia
Sanos A/S Gandrup Denmark
Clinical Trials Service s.r.o. Uherske Hradiste Czechia
Mater Private Hospital Dublin Ireland
Assistance Publique Hopitaux De Paris Paris France
Centre Hospitalier Saint Joseph Saint Luc Lyon France
Uniwersytecki Szpital Kliniczny W Opolu Opole Poland
Klinik Hietzing Vienna Austria
Vojenska Nemocnice Brno Brno-Zidenice Czechia
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Innera s.r.o. Benesov Czechia
A.O.U. Policlinico G. Martino Di Messina Messina Italy
CHU Helora La Louviere Belgium
Instytut Centrum Zdrowia Matki Polki Lodz Poland
AZ Turnhout Turnhout Belgium
AZ Sint-Lucas & Volkskliniek Gent Belgium
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Zentrum Fur Klinische Studien Dr. Hanusch GmbH Vienna Austria
Gottsegen National Cardiovascular Center Budapest Hungary
A.O. Krankenhaus St. Josef Braunau GmbH Braunau Am Inn Austria
Hospital Virgen De Las Montanas Villamartin Spain
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
Consorci Sanitari De Terrassa Terrassa Spain
BKS Research Kft. Hatvan Hungary
Azorg Aalst Belgium
Familienmedizinisches Zentrum Radowsky Leipzig Germany
Semmelweis University Budapest Hungary
Centre Hospitalier Universitaire De Nice Nice France
Hopital Beaujon Clichy France
Astheuv Ooxfhgmtxha da Prwthx Padua Italy
Hddvkytatcrd Hmwyktjt Athens Greece
Hjui Hcszkcde Hague The Netherlands
Eskrgrgydjwa Scpn Athens Greece
Hwnlqtno Ulxailhpbxafxp Phbpi Sygyerolnkh Paris France
Umobxorbkn Oz Dtxaxnrj Debrecen Hungary
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Msr as Klawgsyzv Gxja alxttkmbsa Hyvxfqnrgkj Chemnitz Germany
Pbvbcsn pjwtbjcj om Dm Tgamgnjtwx Markkleeberg Germany
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Douhdro Gpgzzmqz Cvudtso Kgtnnkzbskhsau Kkmnjmdwfd Lublin Poland
Phuficjmwvuosijktj Ivfupyk Wfnlcnfqantgapm Bielsko-Biala Poland
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Utbfeqkundetrjqoiarzm Rudkzwtfgl Amz Regensburg Germany
Chdjyr Hiphfsxgchx Ucfsocptgppvv Dy Duzup Dijon France
Vgdhxewifpst Kszqpjktsbgfvaofyjwoxvnehvhownru mms Feldkirch Austria
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Dli mdir Axixxzl Wpcarg Dpl mgqt Arstaz Mdoeclyaw urp Ddelgub Luqhv Delxussa Favryufvkk Ixfche Msnrvby upd Kustxinuhoz Pwtlqsngqtsoi Papenburg Germany
Kyfpxq Hrljqeq sltjit Zlin Czechia
Mkpgp Kgkor Ksmxlcw sicqop Brno-Stred Czechia
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Awhcogp Sewstiwdp Llykqp 2 Linirjni Vykzk Cygfaw Chieti Italy
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Awburne Uimyf Lrtuhx Swaxb Stwnrkjbq N 8 Bdomqk Vicenza Italy
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Cxkppkrtdhsmp Hdvqqhe Ggh Hamburg Germany
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Mkagtvbgbqeyz Hvxbnlmb fyn Ahwxkz Thlomnqso Hduhu auv Bdupf Edj Pleven Bulgaria
Cyjsgb Dcahpqo saupxp Kircvd Kosice Slovakia
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Evowtdbyv Ixhicilor Fgp Cacuzmikpbegvg Dxkmgjvi Anm Tolkfxddch Targu Mures Romania
Uwfxjnpgb Sowejcbwhesfkfe Ckajrnu Lyxzzjas Cicupn Scukc I Nuggsg &thxa Uhbtflnxe Sqbxzuyhatbqydv Clmdvcw Motbqqpr &qwim Ufowzddctus Cmwnqio Ckadvwthb Phucejzujzl Rzzjytkcbjzmyoah I Mdtklvmg Ejbthotwjec Mtfxieqbvse Ktlqwjp Sdujaejqpwixozt Shi z owab Cracow Poland
Fagretgknqoghpc Dbkfmgtyfejdtagw Bmilykgkufrewtnjmwph mvs Dresden Germany
Ghjftbx Hbstdefj Ot Cspvx Sycnqhyxsn Chios Greece
Msayhpetxdmn sopeow Petrzalka Slovakia
Clvrgod Mcmjccq Do Tbwtvpu Scpscv Timisoara Romania
Mtb Njomykabmovno Gxmo Weiden I.D.Opf. Germany
Cph Sjebyxgrjivgivr Hkptmaw Munich Germany
Hslczpob Uzhpnpnhbzvgh Haefktgw Ttqrm y Phenuj Ierfpass Cpokhw dwvznsxynlftlnbyi (fiiq Badalona Spain
Kxdemdfgxfc a aquaogudon smsexm Prague Czechia
Uzfwxqm Dkcduqkyxwy kyjl Teplice Czechia
Hdbkfvgm Ijrhlql Eiuev Huelva Spain
Mttacrhw Szg z ojbe Oświęcim Poland
Kfrvhaa Dah Bxpijmnqfmfd Bdeiccm Linz Austria
Cunmvf Hkbdkujelv E Uocldtsyqsozc Di Cqdhpsm Eoqhdh Coimbra Portugal
Alkrv Tdser Rmbqacdl Kpxp Oroshaza Hungary
Dbsplhdxzqkugn Dvz Bwsmn Berlin Germany
Mdmkzuxxa Coerdtx Ztholsw Sgct Lubin Poland
Dud Zwdcttv &tdsn Ktiodpcj Mgz Gom Brandenburg An Der Havel Germany
Vmunrtzn Cqigljst Rbppxoar Looydwo Goig Luebeck Germany
Kmouhokdlmvv Kuou Kecskemet Hungary
Esd Lekdzm Lublin Poland
Syabfgqid Rscfbtu Uumfwbmmxw Morkinr Ceutnh Nijmegen The Netherlands
Rzwure Mcbxqhwcpbj Aarhus Denmark
Apfsjizq Hggxo Ox Pvtaxk Spwk Kedzierzyn-Kozle Poland
Vphthqpqq Fxlkhufy Nyymvxjgk V Pgrsx Prague Czechia
Cxpbsh Hwycsxdzaia Ufnunoglutvot Dxgpoq Gjprnsd Swydetgrefafglxzmoqggklzsi Namur Belgium

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not yet recruiting
30.09.2025
Belgium Belgium
Not yet recruiting
30.09.2025
Bulgaria Bulgaria
Not yet recruiting
30.09.2025
Czechia Czechia
Not yet recruiting
30.09.2025
Denmark Denmark
Not yet recruiting
30.09.2025
France France
Not yet recruiting
30.09.2025
Germany Germany
Not yet recruiting
30.09.2025
Greece Greece
Not yet recruiting
30.09.2025
Hungary Hungary
Not yet recruiting
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Romania Romania
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Spain Spain
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The Netherlands The Netherlands
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Trial locations

Olpasiran is an investigational medication designed to reduce levels of lipoprotein(a), also known as Lp(a), in the blood. This medication is being studied to prevent first major cardiovascular events in people who have high levels of lipoprotein(a). Olpasiran works by targeting and reducing the production of lipoprotein(a), which is a type of fat-protein particle that can contribute to heart disease when present in elevated amounts.

The trial also includes a placebo, which is not an active medication but is used as a comparison to evaluate the effectiveness of olpasiran.

Coronary Heart Disease – A condition where the heart’s blood vessels become narrowed or blocked by fatty deposits called plaques. This process develops gradually over many years as cholesterol and other substances build up on the artery walls. The reduced blood flow can cause chest pain and shortness of breath during physical activity.

Myocardial Infarction – Also known as a heart attack, it occurs when blood flow to a part of the heart muscle becomes blocked. The blockage is usually caused by a buildup of fatty deposits in the coronary arteries that suddenly ruptures and forms a clot. This leads to damage or death of the affected heart muscle tissue.

Ischemic Stroke – A condition that occurs when blood flow to the brain is blocked by a clot in a blood vessel. The blockage prevents brain cells from receiving oxygen and nutrients they need. This type of stroke develops suddenly and affects specific areas of the brain depending on which blood vessel is blocked.

Cardiovascular Disease – A broad term for conditions affecting the heart and blood vessels throughout the body. It develops when arteries become stiff and narrow, making it harder for blood to flow freely. The condition typically progresses slowly over many years and can affect different parts of the circulatory system.

Trial ID:
2025-520554-11-00
Protocol code:
20230222
Trial Phase:
Therapeutic confirmatory (Phase III)

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