Clinical trial NCT03664180: Comparison of Anticoagulation Prolongation vs. no Anticoagulation in STEMI Patients After Primary PCI
Official title: Randomized Comparison of Anticoagulation After Primary Percutaneous Coronary Intervention Using Enoxaparin, ACT Guided Unfractionated Heparin or Bivalirudin Prolongation vs. no Anticoagulation To Improve Clinical Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: STEMI - ST Elevation Myocardial Infarction
Keywords: anticoagulantion
post-procedure
STEMI
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
Collaborators: name: Chinese Academy of Medical Sciences, Fuwai Hospital
name: ACTION Study Group (Pitié-Salpêtrière Hospital), Paris, France
First posted: 2018-09-10
Enrollment: 2989
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years old
* STEMI with PPCI of culprit lesion
* Bivalirudin therapy during PPCI
* Signed informed consent form

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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)
timeFrame: 30 days
measure: Primary safety endpoint - The number of event of major bleeding
timeFrame: 30 days
Secondary outcomes:
measure: Secondary ischemic endpoints - The number of event of a composite of all-cause death, non-fatal myocardial infarction, or non-fatal stroke
timeFrame: 30 days
measure: Secondary ischemic endpoints - The number of event of a composite of all-cause death or non-fatal myocardial infarction
timeFrame: 30 days
measure: Secondary ischemic endpoints - The number of cardiovascular death events
timeFrame: 30 days
measure: Secondary ischemic endpoints - The number of stent thrombosis (ARC definite) events
timeFrame: 30 days
measure: Secondary safety endpoints - The number of bleeding events (TIMI, STEEPLE and GUSTO definition)
timeFrame: 30 days
measure: Secondary safety endpoints - The number of thrombocytopenia events
timeFrame: 30 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
Study officials:
References:
citation: Yan Y, Wang X, Guo J, Li Y, Ai H, Gong W, Que B, Zhen L, Lu J, Ma C, Montalescot G, Nie S. Rationale and design of the RIGHT trial: A multicenter, randomized, double-blind, placebo-controlled trial of anticoagulation prolongation versus no anticoagulation after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction. Am Heart J. 2020 Sep;227:19-30. doi: 10.1016/j.ahj.2020.06.005. Epub 2020 Jun 20.