Comparison of Anticoagulation Prolongation vs. no Anticoagulation in STEMI Patients After Primary PCI
- Conditions
- STEMI - ST Elevation Myocardial Infarction
- Interventions
- Registration Number
- NCT03664180
- Lead Sponsor
- Beijing Anzhen Hospital
- Brief Summary
The RIGHT study is a large randomized study dedicated to post-PPCI anticoagulation in STEMI patients. The investigators propose to evaluate the clinical efficacy and safety of anticoagulation prolonged for at least 48 hours after the procedure vs. no prolongation of anticoagulation after procedure in patients with STEMI treated with bivalirudin during PPCI (primary hypothesis). When allocated to anticoagulation prolongation by randomization, the subject will be assigned to UFH, enoxaparin or bivalirudin (same regimen allocated by centre) for at least 48 hours after PPCI. The results from this study are expected to provide guidance on the risk/benefit of post-procedural anticoagulation in patients with STEMI.
- Detailed Description
A minor change of time of randomization after prolongation of bivalirudin infusion at PCI dose up to 4 hours on protocol at September 19,2018. Reasons: a minor change concerning the timing of randomization considering the current local practice in some centers that use the 4 hour infusion of bivalirudin just after PCI. It remains in agreement with the current international guidelines and with the drug label in China. There is no change in drugs used and doses of these drugs once the randomization occurs.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2989
- Age ≥18 years old
- STEMI with PPCI of culprit lesion
- Bivalirudin therapy during PPCI
- Signed informed consent form
- Patients with a formal indication for anticoagulation after PPCI (e.g. atrial fibrillation, left-ventricular thrombus, intra-aortic balloon pump, pulmonary embolism, mechanical heart valve)
- Patients with any indication for chronic anticoagulation
- Patient with previous lytic treatment
- Patient with previous coronary artery bypass graft surgery
- Cardiogenic shock, malignant ventricular arrhythmia, or mechanical complications
- Any anticoagulation other than bivalirudin started after the procedure before randomization
- Estimated body weight of >120 kg or <45kg
- BP ≥180/110mmHg at randomization
- Any bleeding diathesis or severe hematologic disease or history of intracerebral mass, aneurysm, arteriovenous malformation, recent (<6months) ischemic stroke or TIA, recent (<6months) intracranial hemorrhage or, gastrointestinal or genitourinary bleeding within the past 2 weeks
- History of heparin-induced thrombocytopenia
- Suspected acute aortic dissection (AAD)
- Major surgery within 1 month
- A planned elective surgical procedure that would necessitate an interruption in treatment with P2Y12 inhibitors in the next 6 months after enrollment
- Known PLT≤100×109 or HGB≤10g/L
- Known transaminase >3-fold ULN, or CCr<30ml/min
- Known allergy to any study drug
- Pregnancy or lactation
- Noncardiac coexisting conditions that could limit life expectancy to less than 1 year
- Current participation in an investigational drug or device trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description No anticoagulation Bivalirudin placebo - No anticoagulation Unfractionated heparin placebo - No anticoagulation Enoxaparin placebo syringe - anticoagulation Bivalirudin - anticoagulation Unfractionated heparin - anticoagulation Enoxaparin -
- Primary Outcome Measures
Name Time Method Primary efficacy endpoint - number of event of a composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, stent thrombosis (definite) or urgent revascularization (any vessel) 30 days The number of event of a composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, stent thrombosis (definite) or urgent revascularization (any vessel) within 30 days after randomization
Primary safety endpoint - The number of event of major bleeding 30 days The number of event of major bleeding (BARC 3 to 5) within 30 days after randomization
- Secondary Outcome Measures
Name Time Method Secondary ischemic endpoints - The number of event of a composite of all-cause death, non-fatal myocardial infarction, or non-fatal stroke 30 days The number of event of a composite of all-cause death, non-fatal myocardial infarction, or non-fatal stroke within 30 days after randomization
Secondary ischemic endpoints - The number of event of a composite of all-cause death or non-fatal myocardial infarction 30 days The number of event of a composite of all-cause death or non-fatal myocardial infarction within 30 days after randomization
Secondary ischemic endpoints - The number of cardiovascular death events 30 days The number of cardiovascular death event within 30 days after randomization
Secondary ischemic endpoints - The number of stent thrombosis (ARC definite) events 30 days The number of stent thrombosis (ARC definite) event within 30 days after randomization
Secondary safety endpoints - The number of bleeding events (TIMI, STEEPLE and GUSTO definition) 30 days The number of bleeding events (TIMI, STEEPLE and GUSTO definition) within 30 days after randomization
To demonstrate that post-procedure anticoagulation with UFH, enoxaparin or bivalirudin as compared to their placebo is associated to lower rate of the composite endpoint of major bleeding according to TIMI, STEEPLE and GUSTO definitions within the first 30 days after randomization.Secondary safety endpoints - The number of thrombocytopenia events 30 days The number of thrombocytopenia events within 30 days after randomization
To demonstrate superiority of a strategy of post-procedure anticoagulation with UFH, enoxaparin or bivalirudin as compared to their placebo by the time from randomization to the first occurrence of any event of the Thrombocytopenia endpoint over 30 days of follow-up.
Trial Locations
- Locations (1)
Beijing Anzhen Hospital, Capital Medical University
🇨🇳Beijing, China