Evaluating low and standard doses of Ticagrelor for heart patients after stent placement

A Randomized Non-inferiority Study of Low-dose and Standard-dose Ticagrelor After Intervention for Acute Coronary Syndrome

This study is testing whether a lower or standard dose of Ticagrelor, along with Aspirin, can help heart patients in China who have had a stent placed to prevent serious heart and brain problems over the next year.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2120 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Shanghai Tong Ren Hospital (Academic / other)
• Locations: 8 sites (Taishan, Guangdong and 7 other locations)
• Trial ID: NCT04255602 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of two different doses of Ticagrelor (60mg and 90mg) combined with Aspirin in preventing major cardiovascular and cerebrovascular events in patients who have undergone drug-eluting stent implantation for acute coronary syndrome. The trial focuses on Chinese patients and aims to determine which dosage is more effective over a one-year period following the intervention. Participants must be at least 18 years old and provide informed consent before the procedure.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have successfully undergone percutaneous coronary intervention with drug-eluting stents for acute coronary syndrome.

Not a fit: Patients with active bleeding, known hypersensitivity to study medications, or significant non-cardiac co-morbid conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for preventing serious cardiovascular events in patients with acute coronary syndrome.

How similar studies have performed: Other studies have shown varying success with different antiplatelet therapies, but this specific comparison of Ticagrelor doses in this population is novel.

Eligibility criteria

Inclusion Criteria:

1. Subject must be at least 18 years of age
2. Patients should have undergone successful percutaneous coronary intervention with drug-eluting stent for acute coronary syndrome
3. Subject understand the study requirements and the treatment procedures and provided informed consent before the procedure

Exclusion Criteria:

1. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
2. Active bleeding
3. Known hypersensitivity or contraindication to study medications
4. Non-cardiac co-morbid conditions are present with life expectancy \<2 year or that may result in protocol non-compliance (per site investigator's medical judgment).
5. Subjects with Cerebral hemorrhage history
6. Subjects with stroke history in half a year
7. subjects with malignant tumor
8. subjects with whom oral anticoagulants are needed

Where this trial is running

Taishan, Guangdong and 7 other locations

• Taishan people's hospital — Taishan, Guangdong, China (Recruiting)
• South East of Shandong hospital — Liaocheng, Shandong, China (Recruiting)
• zhangshan hospital, Fudan University — Shanghai, Shanghai, China (Not_yet_recruiting)
• shanghai Tongren hospital — Shanghai, Shanghai, China (Recruiting)
• Minhang hospital, Fudan University — Shanghai, Shanghai, China (Not_yet_recruiting)
• Songjiang hospital, Shanghai jiaotong university, school of medicine — Shanghai, Shanghai, China (Not_yet_recruiting)
• Ningbo 4th hospital — Xiangshan, Zhejiang, China (Recruiting)
• Yanzhou branch of affiliated hospital of Jining medical university — Jining, China (Not_yet_recruiting)

Study contacts

• Principal investigator: Lei Hou, Doctor — Shanghai Tongren Hospital
• Study coordinator: Lei Hou, Doctor

Conditions Acute Coronary Syndrome; Coronary Stent Implantation