Study on the Safety of Ticagrelor and Aspirin in Patients with Acute Coronary Syndrome

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What is this study about?

This clinical trial is focused on studying a heart condition known as Acute Coronary Syndrome (ACS). This condition occurs when the blood supply to the heart is suddenly blocked, which can lead to a heart attack. The study is evaluating the safety and effectiveness of two different treatment strategies that involve the use of a medication called ticagrelor. Ticagrelor is an antiplatelet drug, which means it helps prevent blood clots by stopping platelets (a type of blood cell) from sticking together. The study will compare these strategies to the standard treatment, which is a combination of two antiplatelet drugs.

Participants in the study will be randomly assigned to one of the treatment strategies or a standard treatment group. The study will last for up to 12 months, during which time participants will take the medication as prescribed and attend regular check-ups. The main goal is to monitor the safety of the treatments, particularly looking at any bleeding events that may occur. Bleeding is a known risk with antiplatelet drugs, and the study will track different types of bleeding, such as those that require medical attention or are life-threatening.

In addition to monitoring bleeding, the study will also look at other important health outcomes, such as heart attacks, strokes, and overall survival. The results will help determine which treatment strategy is safest and most effective for people with Acute Coronary Syndrome. This information could lead to improved treatment options for patients with this heart condition in the future.

1 joining the study

Upon joining the study, the participant is required to have signed an informed consent form. This indicates understanding of the study’s purpose and procedures.

The participant must be diagnosed with acute coronary syndrome (ACS), which includes conditions like ST-elevation myocardial infarction (STEMI), non-ST elevation myocardial infarction (NSTEMI), or unstable angina (UA).

2 initial treatment phase

The participant will begin treatment with a standard dual antiplatelet therapy (DAPT). This involves taking aspirin and ticagrelor.

Aspirin is administered as a 100 mg gastro-resistant tablet, taken orally.

Ticagrelor is provided in two forms: a 60 mg film-coated tablet and a 90 mg orodispersible tablet, both taken orally.

3 treatment adjustment

The study aims to evaluate two ticagrelor-based de-escalation strategies. This means the dosage or combination of medications may be adjusted based on the participant’s response and safety assessments.

The primary goal is to ensure the safety of the participant while maintaining the effectiveness of the treatment.

4 monitoring and follow-up

Throughout the study, the participant will be monitored for any signs of bleeding, as defined by the Bleeding Academic Research Consortium (BARC) criteria.

The study will track the first occurrence of type 2, 3, or 5 bleeding within 12 months. Type 2 bleeding requires medical attention, type 3 involves significant blood loss or medical intervention, and type 5 is fatal bleeding.

5 completion of study

The study is expected to conclude by June 30, 2026. At this point, the participant’s involvement in the study will end, and final assessments will be conducted to evaluate the outcomes of the treatment strategies.

Who Can Join the Study?

The person must have signed an Informed Consent Form, which means they agree to participate in the study and understand what it involves.
The person must be 18 years old or older.
The person must be able to follow the study’s rules and instructions and is expected to complete the study.
The person must have been diagnosed with Acute Coronary Syndrome (ACS), which includes conditions like ST-elevation myocardial infarction (STEMI), non-ST elevation myocardial infarction (NSTEMI), or unstable angina (UA).
For those with STEMI, they must meet these three conditions:
- New changes in the heart’s electrical activity, seen on an ECG, that meet specific criteria.
- A plan to perform a procedure called primary percutaneous coronary intervention (PCI).
- Changes in a heart-related protein called cardiac troponin, indicating heart damage.
For those with NSTEMI-ACS, they must meet at least two of these conditions:
- Symptoms that suggest a lack of blood flow to the heart.
- Changes in the heart’s electrical activity, seen on an ECG, indicating a lack of blood flow to the heart.
- Changes in cardiac troponin levels, indicating heart damage.
Additionally, they must have at least one of these conditions:
- Be 60 years old or older.
- Have had a previous heart attack or heart surgery called coronary artery bypass grafting.
- Have significant narrowing (50% or more) in two or more heart arteries.
- Have had a previous ischemic stroke or Transient Ischemic Attack (TIA), which are types of brain events.
- Have significant narrowing (50% or more) in neck arteries or have had a procedure to improve blood flow to the brain.
- Have diabetes mellitus, a condition affecting blood sugar levels.
- Have peripheral artery disease, which affects blood flow in the limbs.
- Have chronic kidney disease with reduced kidney function.

Who Cannot Join the Study?

Patients who have a history of severe allergic reactions to the study medications.
Patients with active bleeding or a high risk of bleeding, which means they are more likely to bleed easily.
Patients with a history of stroke, which is when blood flow to the brain is interrupted.
Patients with severe liver disease, meaning their liver is not working properly.
Patients who are pregnant or breastfeeding.
Patients who are currently participating in another clinical trial.
Patients with any condition that the study doctors believe would make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi	Lodz	Poland
4 Wojskowy SzpitaKliniczny Z Polikliniką Samodzielny Publiczny ZakładOpieki ZdrowotneWe Wrocławiu	Wroclaw	Poland
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland
Szpital Bielanski Im.Ks.Jerzego Popieluszki samodzielny publiczny zakład opieki zdrowotnej	Warsaw	Poland

Other Sites

Site Name	City	Country
Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego	Lodz	Poland
Szpital Grochowski Im.Dr Med. Rafała Masztaka Sp. z o.o.	Warsaw	Poland
Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu	Torun	Poland
1 Wojskowy Szpital Kliniczny Z Poliklinika samodzielny publiczny zakład opieki zdrowotnej W Lublinie	Lublin	Poland
Wojewodzki Szpital Specjalistyczny W Olsztynie	Olsztyn	Poland
Wojewodzki Szpital Zespolony W Kielcach SPZOZ	Kielce	Poland
Wojewodzki Szpital Zespolony W Elblagu SPZOZ	Elblag	Poland
Szpital Uniwersytecki Nr 1 Im. Dr. A. Jurasza W Bydgoszczy	Bydgoszcz	Poland
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy	Bydgoszcz	Poland
Gornoslaskie Centrum Mwdyczne	Katowice	Poland
American Heart Of Poland S.A.	Kedzierzyn-Kozle	Poland
Rylxsfmumg Spkknua Scabymnrtbbjfpu Idx Dkw Wtpmwmpnkq Bqfusrklmqkg	Grudziadz	Poland
Mlpzxxk Ululcdrdoj Oy Ggmidh	Gdansk	Poland
Pvwtntieimb Sbhrwtm Situnellhtbgseo Ixr Jbwe Pgbhq Ib W Nabyk Tqdcn	Nowy Targ	Poland
Sqddtxn Sgmuceizhsckbew Dyrlw Spuozguq W Skbjcekgmjr	Sandomierz	Poland
1y Wxhhkipj Sxysrxe Kruotqgvb Z Pnzxuloymoq	Bydgoszcz	Poland
Wqnrghaeuhdjuujrjowr Sgwtdfd Mdvzrzi Ipl Dl Eccph Wolyavdwhwka sqmibgmrlpv pmgtytmvp zqmtdi ozxzal zwxpxxokls W Bwacynfxgb	Bydgoszcz	Poland
Wafstpjbdv Spjolwc Serfaclthtwxykw img Bndogboprkmqset Kcflgfx Jcqibkw Pldoxtptqba	Wloclawek	Poland
Swsnzmi Sqatpuktinwkukb W Pmet Iyi Sbjtbzyiyg Sxpxeitw	Pila	Poland

Trial status

Country	Status	Recruitment Start
Poland	Not recruiting	20.09.2021

Trial locations

Investigated drugs:

Ticagrelor is a medication used to prevent blood clots in people who have had a heart attack or have other heart-related issues. It works by making the blood less sticky, which helps to prevent clots from forming in the blood vessels. In this trial, ticagrelor is being used as part of a strategy to reduce the intensity of antiplatelet therapy after an acute coronary syndrome event.

Standard Dual Antiplatelet Therapy (DAPT) typically involves the use of two medications that help prevent blood clots. This therapy is commonly used after procedures like stent placement in the heart to keep the blood vessels open and prevent clotting. The trial is comparing the safety of reducing the intensity of this therapy using ticagrelor-based strategies.

Investigated diseases:

Acute coronary syndrome

Acute Coronary Syndrome (ACS) – Acute Coronary Syndrome is a term used to describe a range of conditions associated with sudden, reduced blood flow to the heart. It often results from the buildup of fatty deposits in and on the walls of coronary arteries, which can rupture and form a clot. This condition can lead to chest pain or discomfort, often described as a feeling of pressure or tightness in the chest. ACS can also cause shortness of breath, nausea, or lightheadedness. The progression of ACS can lead to more severe heart conditions, such as a heart attack, if not managed properly. It is a critical condition that requires immediate medical attention to restore blood flow and prevent heart damage.

Trial ID:

2024-518090-34-00

Protocol code:

2019/ABM/01/00009

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Safety of Ticagrelor and Aspirin in Patients with Acute Coronary Syndrome

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