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

NCT03664180 | Completed Phase 4 DMC

• 2 other identifiers: 2018024XBJUHFRIGHT201802
• Study Type: interventional
• Target: 2,989
• Locations: 1 country
• Sites: 1

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.

Conditions

STEMI - ST Elevation Myocardial Infarction

Keywords

anticoagulantion; post-procedure; STEMI

Outcome Measures

Primary Outcomes (2)

• 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 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 Outcomes (6)

• Secondary ischemic endpoints - The number of event of a composite of all-cause death, non-fatal myocardial infarction, or non-fatal stroke

  30 days

• Secondary ischemic endpoints - The number of event of a composite of all-cause death or non-fatal myocardial infarction

  30 days

• Secondary ischemic endpoints - The number of cardiovascular death events

  30 days

• Secondary ischemic endpoints - The number of stent thrombosis (ARC definite) events

  30 days

• Secondary safety endpoints - The number of bleeding events (TIMI, STEEPLE and GUSTO definition)

  30 days

Study Arms (2)

anticoagulation

EXPERIMENTAL

Drug: Bivalirudin; Drug: Enoxaparin; Drug: Unfractionated heparin

No anticoagulation

PLACEBO COMPARATOR

Drug: Bivalirudin placebo; Drug: Enoxaparin placebo syringe; Drug: Unfractionated heparin placebo

Interventions

Bivalirudin DRUG

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

anticoagulation

Enoxaparin DRUG

40mg/d s.c.for at least 48h after the procedure or until discharge from CCU if it occurs later

anticoagulation

Unfractionated heparin DRUG

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

anticoagulation

Bivalirudin placebo DRUG

Matching placebo IV infusion for at least 48h after the procedure or until discharge from CCU if it occurs later

No anticoagulation

Enoxaparin placebo syringe DRUG

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.

No anticoagulation

Unfractionated heparin placebo DRUG

Matching placebo IV infusion for at least 48h after the procedure or until discharge from CCU if it occurs later.

No anticoagulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator
• ACTION Study Group (Pitié-Salpêtrière Hospital), Paris, France: collaborator

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, 100029, China

Location

Related Publications (2)

• 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.

  PMID: 32663660 BACKGROUND

• Yan Y, Guo J, Wang X, Wang G, Fan Z, Yin D, Wang Z, Zhang F, Tian C, Gong W, Liu J, Lu J, Li Y, Ma C, Vicaut E, Montalescot G, Nie S; RIGHT Investigators. Postprocedural Anticoagulation After Primary Percutaneous Coronary Intervention for ST-Segment-Elevation Myocardial Infarction: A Multicenter, Randomized, Double-Blind Trial. Circulation. 2024 Apr 16;149(16):1258-1267. doi: 10.1161/CIRCULATIONAHA.123.067079. Epub 2024 Feb 26.

  PMID: 38406848 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

bivalirudin; Enoxaparin; Heparin

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Director, Emergency & Critical Care Center

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: September 10, 2018
• Study Start: January 11, 2019
• Primary Completion: November 23, 2022
• Study Completion: November 23, 2022
• Last Updated: May 3, 2023

Record last verified: 2023-04

Locations

CN (1)