Comparing Ticagrelor with Low-dose Aspirin to Regular Aspirin for Heart Patients
Safety and Efficacy of Ticagrelor With Low-dose Aspirin Versus Regular Aspirin in Patients With Acute Coronary Syndrome at High-risk for Ischemia After Percutaneous Coronary Intervention: A Randomized Controlled Study
This study is testing whether Ticagrelor with low-dose Aspirin is safer and more effective than Ticagrelor with regular-dose Aspirin for heart patients at high risk after a procedure to open blocked arteries.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fu Wai Hospital, Beijing, China Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT04240834 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and effectiveness of Ticagrelor combined with low-dose Aspirin versus standard dual anti-platelet therapy in patients with acute coronary syndrome (ACS) who are at high risk for ischemic events following percutaneous coronary intervention (PCI). A total of 1220 patients will be enrolled and randomly assigned to receive either Ticagrelor with low-dose Aspirin or Ticagrelor with regular-dose Aspirin for a duration of 12 months. The primary goal is to assess the impact on major adverse cardiac and cerebral events, while secondary objectives include evaluating bleeding events, platelet function inhibition, and medication adherence. This research seeks to provide new insights into anti-platelet protocols for high-risk ACS patients.
Who should consider this trial
Good fit: Ideal candidates are patients with acute coronary syndrome at high risk for ischemic events who have undergone successful PCI with at least one drug-eluting stent.
Not a fit: Patients who do not have acute coronary syndrome or those who are not at high risk for ischemic events may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols that reduce the risk of ischemic events in high-risk heart patients.
How similar studies have performed: Other studies have shown promising results with similar anti-platelet approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ACS patients at high risk for ischemic events after successful PCI with implantation of at least one drug eluting stent * Able and willing to provide informed consent and participate in 12 months follow-up period * Able to receive DAPT treatment * Enrollment into the study will require meeting at least one angiographic or clinical inclusion and none of the exclusion criteria. Clinical inclusion criteria: 1. Family history of premature coronary heart disease (Coronary heart disease in first-degree male relative \<55 years old or in first-degree female relative \<65 years old) 2. Repeated myocardial infarction 3. Positive serum cardiac troponin I/T 4. Combined with at least one organ/system with atherosclerotic disease (e.g. intracranial or peripheral arteries) 5. Type 2 diabetes mellitus under medication 6. Chronic kidney disease (eGFR\<60 mL/min/1.73 m2 or CrCl\<60ml/min) Angiographic Inclusion Criteria: 1. LM lesion requiring stents 2. Proximal LAD lesion(s) requiring stents 3. Bypass grafts lesion(s) requiring stents 4. Overall stent length ≥60 mm 5. History of in-stent thrombosis 6. Bifurcation lesions requiring at least 2 stents 7. Over two vessels lesions requiring stents 8. Calcified target lesion(s) requiring atherectomy 9. The intraoperative occurrence of no-reflow or slow-flow 10. Compressed branch vessels with a diameter of at least 2.0 mm failing to reach flow restoration (at least TIMI 3) Exclusion Criteria: * Need for chronic oral anticoagulation * With cardiomyopathy（HCM/DCM/RCM） * With severe ventricular arrhythmia requiring ICD implantation * With chronic respiratory disease (COPD, asthma, chronic bronchitis, pulmonary heart disease) * With severe infectious disease（active hepatitis B, active hepatitis C, AIDS） * With hematological disorders（thrombocytopenia, severe anemia, leukaemia） * With severe liver disease or kidney failure * With malignant tumor * With cognitive impairment * Unable or unwilling to provide informed consent or undergo follow-up
Where this trial is running
Beijing, Beijing Municipality
- Fuwai Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Haiyan Qian, MD, PhD — Fuwai Hospital, Beijing, China
- Study coordinator: Haiyan Qian, MD, PhD
- Email: ahqhy712@163.com
- Phone: +8613811386143
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.