Comparison of Anticoagulation Prolongation vs. no Anticoagulation in STEMI Patients After Primary PCI

STEMI - ST Elevation Myocardial Infarction Clinical Trial

— RIGHT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03664180
• Other study ID #: 2018024X
• Secondary ID: BJUHFRIGHT201802
• Status: Completed
• Phase: Phase 4
• Start date: January 11, 2019
• Est. completion date: November 23, 2022

Study information

• Verified date: April 2023
• Source: Beijing Anzhen Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 2989
• Est. completion date: November 23, 2022
• Est. primary completion date: November 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• STEMI - ST Elevation Myocardial Infarction

Intervention

Drug:
• Bivalirudin
IV infusion of 0.2 mg/kg/h (low-rate infusion) for at least 48h after the procedure or until discharge from CCU if it occurs later
• Enoxaparin
40mg/d s.c.for at least 48h after the procedure or until discharge from CCU if it occurs later
• Unfractionated heparin
IV infusion of 10 U/kg/h (maximum 1000 U) initially, adjusted to maintain ACT between 150 and 220 seconds for at least 48h after the procedure or until discharge from CCU if it occurs later
• Bivalirudin placebo
Matching placebo IV infusion for at least 48h after the procedure or until discharge from CCU if it occurs later
• Enoxaparin placebo syringe
Placebo syringe will be only prepared by a designated unblended medical professional on site. Placebo syringe will be presented in identical containers as a clear, colorless, sterile liquid of saline.Subcutaneous injection once a day for at least 48 hours after the procedure or until discharge from CCU if it occurs later.
• Unfractionated heparin placebo
Matching placebo IV infusion for at least 48h after the procedure or until discharge from CCU if it occurs later.

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital, Capital Medical University	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital	ACTION Study Group (Pitié-Salpêtrière Hospital), Paris, France, Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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	30 days
Primary	Primary safety endpoint - The number of event of major bleeding	The number of event of major bleeding (BARC 3 to 5) within 30 days after randomization	30 days
Secondary	Secondary ischemic endpoints - The number of event of a composite of all-cause death, non-fatal myocardial infarction, or non-fatal stroke	The number of event of a composite of all-cause death, non-fatal myocardial infarction, or non-fatal stroke within 30 days after randomization	30 days
Secondary	Secondary ischemic endpoints - The number of event of a composite of all-cause death or non-fatal myocardial infarction	The number of event of a composite of all-cause death or non-fatal myocardial infarction within 30 days after randomization	30 days
Secondary	Secondary ischemic endpoints - The number of cardiovascular death events	The number of cardiovascular death event within 30 days after randomization	30 days
Secondary	Secondary ischemic endpoints - The number of stent thrombosis (ARC definite) events	The number of stent thrombosis (ARC definite) event within 30 days after randomization	30 days
Secondary	Secondary safety endpoints - The number of bleeding events (TIMI, STEEPLE and GUSTO definition)	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.	30 days
Secondary	Secondary safety endpoints - The number of thrombocytopenia events	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.	30 days