- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03664180
Comparison of Anticoagulation Prolongation vs. no Anticoagulation in STEMI Patients After Primary PCI (RIGHT)
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 Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Beijing, China, 100029
- Beijing Anzhen Hospital, Capital Medical University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: anticoagulation
|
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
40mg/d s.c.for at least 48h after the procedure or until discharge from CCU if it occurs later
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
|
Placebo Comparator: No anticoagulation
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Matching placebo IV infusion for at least 48h after the procedure or until discharge from CCU if it occurs later
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.
Matching placebo IV infusion for at least 48h after the procedure or until discharge from CCU if it occurs later.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
Time Frame: 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
|
30 days
|
Primary safety endpoint - The number of event of major bleeding
Time Frame: 30 days
|
The number of event of major bleeding (BARC 3 to 5) within 30 days after randomization
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary ischemic endpoints - The number of event of a composite of all-cause death, non-fatal myocardial infarction, or non-fatal stroke
Time Frame: 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
|
30 days
|
Secondary ischemic endpoints - The number of event of a composite of all-cause death or non-fatal myocardial infarction
Time Frame: 30 days
|
The number of event of a composite of all-cause death or non-fatal myocardial infarction within 30 days after randomization
|
30 days
|
Secondary ischemic endpoints - The number of cardiovascular death events
Time Frame: 30 days
|
The number of cardiovascular death event within 30 days after randomization
|
30 days
|
Secondary ischemic endpoints - The number of stent thrombosis (ARC definite) events
Time Frame: 30 days
|
The number of stent thrombosis (ARC definite) event within 30 days after randomization
|
30 days
|
Secondary safety endpoints - The number of bleeding events (TIMI, STEEPLE and GUSTO definition)
Time Frame: 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. |
30 days
|
Secondary safety endpoints - The number of thrombocytopenia events
Time Frame: 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. |
30 days
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Myocardial Infarction
- Infarction
- ST Elevation Myocardial Infarction
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Protease Inhibitors
- Antithrombins
- Serine Proteinase Inhibitors
- Anticoagulants
- Heparin
- Bivalirudin
- Enoxaparin
- Calcium heparin
- Enoxaparin sodium
- Hirudins
Other Study ID Numbers
- 2018024X
- BJUHFRIGHT201802 (Other Identifier: Beijing United Heart Foundation)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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