NCT04240834 Ticagrelor With Low-dose Versus Regular Aspirin in Patients With Acute Coronary Syndrome (ACS) at High-Risk for Ischemia After Percutaneous Coronary Intervention
| NCT ID | NCT04240834 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Fu Wai Hospital, Beijing, China |
| Condition | Acute Coronary Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,220 participants |
| Start Date | 2021-02-01 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 1,220 participants in total. It began in 2021-02-01 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The present study is aimed to compare the safety and efficacy of Ticagrelor with low-dose Aspirin versus standard dual anti-platelet therapy (DAPT) in patients with acute coronary syndrome (ACS) at high risk for ischemic events after percutaneous coronary intervention (PCI) and stent implantation.
Eligibility 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
Contact & Investigator
Haiyan Qian, MD, PhD
PRINCIPAL INVESTIGATOR
Fuwai Hospital, Beijing, China
Frequently Asked Questions
Who can join the NCT04240834 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Coronary Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04240834 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04240834 currently recruiting?
Yes, NCT04240834 is actively recruiting participants. Contact the research team at ahqhy712@163.com for enrollment information.
Where is the NCT04240834 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT04240834 clinical trial?
NCT04240834 is sponsored by Fu Wai Hospital, Beijing, China. The principal investigator is Haiyan Qian, MD, PhD at Fuwai Hospital, Beijing, China. The trial plans to enroll 1,220 participants.