Comparing Clopidogrel and Ticagrelor for heart attack patients after stent placement
Twice a Day Clopidogrel vs Ticagrelor in Reducing Major Cardiac Events in Patients With Acute STEMI Undergoing Primary Percutaneous Intervention- TADCLOT- a Double Blind Randomized Controlled Trial
This study is testing whether taking Clopidogrel or Ticagrelor after getting a stent can better prevent serious heart problems in patients who have just had a heart attack.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 2200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Institute of Cardiovascular Diseases, Pakistan Academic / other |
| Locations | 1 site (Karachi, SIndh) |
| Trial ID | NCT06318481 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the safety and efficacy of a twice-daily regimen of Clopidogrel versus Ticagrelor in reducing major adverse cardiac events in patients who have undergone primary percutaneous coronary intervention (PCI) for acute ST elevation myocardial infarction (STEMI). The study is designed as a double-blind randomized controlled trial, focusing on the critical first 30 days post-PCI when patients are at heightened risk for stent thrombosis. By analyzing the outcomes of these two antiplatelet therapies, the trial seeks to provide insights into optimal treatment strategies for improving patient outcomes following heart attacks.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have experienced an ST-segment elevation myocardial infarction and are undergoing primary PCI.
Not a fit: Patients with STEMI due to stent thrombosis or those with severe comorbidities such as advanced chronic kidney disease or recent major bleeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could lead to improved treatment protocols that significantly reduce the risk of major adverse cardiac events in heart attack patients.
How similar studies have performed: Other studies have shown varying success with antiplatelet therapies in similar patient populations, but this specific comparison of Clopidogrel and Ticagrelor in the context of primary PCI for STEMI is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ST-segment elevation ≥1 mm in ≥ 2 contiguous ECG leads or New or presumably New left bundle branch block * Age ≥18 years * Written informed consent Exclusion Criteria: * Patients with STEMI secondary to stent thrombosis or index event being a complication of PCI within 30 days * Thrombolytic therapy \<24 hours * Platelet count \< 100,000 and Hemoglobin \<10 gm/dl * Pregnancy or lactation * Moderate to severe hepatic impairment * Patients with advanced CKD and those on hemodialysis * Recent ICH or major bleed requiring transfusion * Inability to give informed consent * Participation in another study * Inability to fulfill protocol (living outside the city etc.)
Where this trial is running
Karachi, SIndh
- National Institute of Cardiovascular Diseases — Karachi, SIndh, Pakistan (Recruiting)
Study contacts
- Principal investigator: Abdul Hakeem — Nicvd
- Study coordinator: Abdul Hakeem
- Email: abdulhakeem@gmail.com
- Phone: +923355554342
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.