NCT04240834RecruitingPhase 4
Ticagrelor With Low-dose Versus Regular Aspirin in Patients With Acute Coronary Syndrome (ACS) at High-Risk for Ischemia After Percutaneous Coronary Intervention
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
Source: ClinicalTrials.gov · Last updated 18 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 1220 (estimated)
- First submitted
- 22 Jan 2020
- Start date
- 1 Feb 2021
- Primary completion date
- Dec 2025
- Lead sponsor
- Fu Wai Hospital, Beijing, China
- Diseases
- Coronary artery disease
- NCT number
- NCT04240834
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 1220
- From 1 Feb 2021 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Need for chronic oral anticoagulation
- With cardiomyopathy（HCM/DCM/RCM）
- Unable or unwilling to provide informed consent or undergo follow-up
Who the study is looking for
- 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:
- 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)
- Repeated myocardial infarction
- Positive serum cardiac troponin I/T
- Combined with at least one organ/system with atherosclerotic disease (e.g. intracranial or peripheral arteries)
- Type 2 diabetes mellitus under medication
- Chronic kidney disease (eGFR\<60 mL/min/1.73 m2 or CrCl\<60ml/min)
- Angiographic Inclusion Criteria:
- LM lesion requiring stents
- Proximal LAD lesion(s) requiring stents
- Bypass grafts lesion(s) requiring stents
- Overall stent length ≥60 mm
- History of in-stent thrombosis
- Bifurcation lesions requiring at least 2 stents
- Over two vessels lesions requiring stents
- Calcified target lesion(s) requiring atherectomy
- The intraoperative occurrence of no-reflow or slow-flow
- Compressed branch vessels with a diameter of at least 2.0 mm failing to reach flow restoration (at least TIMI 3)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fuwai Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.