NCT06861374Not yet recruiting
Bivalirudin with Prolonged Infusion During PCI Versus Heparin After Fibrinolytic Therapy
Bivalirudin Plus High-Dose Infusion Versus Heparin Monotherapy in Patients with ST-Segment Elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention After Fibrinolysis: a Randomized Trial
Source: ClinicalTrials.gov · Last updated 6 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This multicenter, randomized controlled trial in China aims to enroll 2,400 patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention (PCI) within 24 hours post-fibrinolysis. Participants will be randomly assigned in a 1:1 ratio to receive either bivalirudin or heparin, with follow-up at 30 days and 1 year. The primary endpoint is a composite of all-cause mortality and Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at 30 days.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 2400 (estimated)
- First submitted
- 3 Mar 2025
- Start date
- May 2025
- Primary completion date
- Mar 2028
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Diseases
- Coronary artery disease
- NCT number
- NCT06861374
What you commit to
- Study type: Interventional
- Planned participants: 2400
- From May 2025 to the primary completion date, Mar 2028
- No sites listed in no 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.
Prior treatment
- Patients in whom the investigators consider inappropriate to participate in this study (eg, have participated in another drug/instrument study or undergoing another drug/instrument study, pregnancy).
Other illness
- Known allergy or contraindications to heparin, bivalirudin, aspirin, or both clopidogrel and ticagrelor
Other
- Not suitable for PCI;
- Mechanical complications (such as ventricular septal rupture, papillary muscle rupture with acute mitral regurgitation, etc.);
- Cardiogenic shock(Killip IV)
- Patients who underwent PCI in past 30 days
Who the study is looking for
- Any age
- STEMI patients received fibrinolysis therapy within 12h of symptom onset and are planned to undergo PCI within 24h of symptom onset.
- Dual antiplatelet drugs must be administrated according to guidelines before PCI (loading doses and maintenance doses of aspirin and clopidogrel or ticagrelor)
- Patients requiring staged revascularization of non-culprit vessels within 30 days may be enrolled. In such cases the same antithrombotic agents and PCI procedures must be used in the staged procedure consistent with the index procedure PCI, in particular the assigned antithrombin agent heparin vs. bivalirudin);
- The subject or legal representative has been informed of the nature of the study, understood the provisions of the protocol, was able to ensure adherence, and signed informed consent.
Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.