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

Primary Purpose

STEMI - ST Elevation Myocardial Infarction

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Bivalirudin
Enoxaparin
Unfractionated heparin
Bivalirudin placebo
Enoxaparin placebo syringe
Unfractionated heparin placebo
Sponsored by
Beijing Anzhen Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for STEMI - ST Elevation Myocardial Infarction focused on measuring anticoagulantion, post-procedure, STEMI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Anzhen Hospital, Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

anticoagulation

No anticoagulation

Arm Description

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
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
Secondary ischemic endpoints - The number of cardiovascular death events
The number of cardiovascular death event within 30 days after randomization
Secondary ischemic endpoints - The number of stent thrombosis (ARC definite) events
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)
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
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.

Full Information

First Posted
August 27, 2018
Last Updated
April 30, 2023
Sponsor
Beijing Anzhen Hospital
Collaborators
Chinese Academy of Medical Sciences, Fuwai Hospital, ACTION Study Group (Pitié-Salpêtrière Hospital), Paris, France
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1. Study Identification

Unique Protocol Identification Number
NCT03664180
Brief Title
Comparison of Anticoagulation Prolongation vs. no Anticoagulation in STEMI Patients After Primary PCI
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 11, 2019 (Actual)
Primary Completion Date
November 23, 2022 (Actual)
Study Completion Date
November 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Anzhen Hospital
Collaborators
Chinese Academy of Medical Sciences, Fuwai Hospital, ACTION Study Group (Pitié-Salpêtrière Hospital), Paris, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
STEMI - ST Elevation Myocardial Infarction
Keywords
anticoagulantion, post-procedure, STEMI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2989 (Actual)

8. Arms, Groups, and Interventions

Arm Title
anticoagulation
Arm Type
Experimental
Arm Title
No anticoagulation
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Bivalirudin
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Intervention Description
40mg/d s.c.for at least 48h after the procedure or until discharge from CCU if it occurs later
Intervention Type
Drug
Intervention Name(s)
Unfractionated heparin
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Bivalirudin placebo
Intervention Description
Matching placebo IV infusion for at least 48h after the procedure or until discharge from CCU if it occurs later
Intervention Type
Drug
Intervention Name(s)
Enoxaparin placebo syringe
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Unfractionated heparin placebo
Intervention Description
Matching placebo IV infusion for at least 48h after the procedure or until discharge from CCU if it occurs later.
Primary Outcome Measure Information:
Title
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)
Description
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
Time Frame
30 days
Title
Primary safety endpoint - The number of event of major bleeding
Description
The number of event of major bleeding (BARC 3 to 5) within 30 days after randomization
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Secondary ischemic endpoints - The number of event of a composite of all-cause death, non-fatal myocardial infarction, or non-fatal stroke
Description
The number of event of a composite of all-cause death, non-fatal myocardial infarction, or non-fatal stroke within 30 days after randomization
Time Frame
30 days
Title
Secondary ischemic endpoints - The number of event of a composite of all-cause death or non-fatal myocardial infarction
Description
The number of event of a composite of all-cause death or non-fatal myocardial infarction within 30 days after randomization
Time Frame
30 days
Title
Secondary ischemic endpoints - The number of cardiovascular death events
Description
The number of cardiovascular death event within 30 days after randomization
Time Frame
30 days
Title
Secondary ischemic endpoints - The number of stent thrombosis (ARC definite) events
Description
The number of stent thrombosis (ARC definite) event within 30 days after randomization
Time Frame
30 days
Title
Secondary safety endpoints - The number of bleeding events (TIMI, STEEPLE and GUSTO definition)
Description
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.
Time Frame
30 days
Title
Secondary safety endpoints - The number of thrombocytopenia events
Description
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.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Beijing Anzhen Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100029
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
32663660
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.
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Comparison of Anticoagulation Prolongation vs. no Anticoagulation in STEMI Patients After Primary PCI

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