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

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ClinicalTrials.gov Identifier: NCT03664180
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : June 12, 2019
Sponsor:
Collaborators:
Chinese Academy of Medical Sciences, Fuwai Hospital
ACTION Study Group (Pitié-Salpêtrière Hospital), Paris, France
Information provided by (Responsible Party):
Shao-Ping Nie, Beijing Anzhen Hospital

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.

Condition or disease Intervention/treatment Phase
STEMI - ST Elevation Myocardial Infarction Drug: Bivalirudin Drug: Enoxaparin Drug: Unfractionated heparin Drug: Bivalirudin placebo Drug: Enoxaparin placebo syringe Drug: Unfractionated heparin placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2856 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 11, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: anticoagulation 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

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

Drug: 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

Placebo Comparator: No anticoagulation Drug: Bivalirudin placebo
Matching placebo IV infusion for at least 48h after the procedure or until discharge from CCU if it occurs later

Drug: 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.

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




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Secondary ischemic endpoints - The number of cardiovascular death events [ Time Frame: 30 days ]
    The number of cardiovascular death event within 30 days after randomization

  4. 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

  5. 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.


  6. 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664180


Contacts
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Contact: Shao-Ping Nie, MD, PhD 86-10-84005256 spnie@ccmu.edu.cn
Contact: Yan Yan, MD +86-10-84005255 eva3321@sina.com

Locations
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China
Beijing Anzhen Hospital, Capital Medical University Recruiting
Beijing, China, 100029
Contact: Shao-Ping Nie, MD, PhD    86-10-84005256    spnie@ccmu.edu.cn   
Principal Investigator: Shao-Ping Nie, MD, PhD         
Sponsors and Collaborators
Beijing Anzhen Hospital
Chinese Academy of Medical Sciences, Fuwai Hospital
ACTION Study Group (Pitié-Salpêtrière Hospital), Paris, France

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Responsible Party: Shao-Ping Nie, Professor of Medicine, Director, Emergency & Critical Care Center, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier: NCT03664180     History of Changes
Other Study ID Numbers: 2018024X
BJUHFRIGHT201802 ( Other Identifier: Beijing United Heart Foundation )
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019

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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

Keywords provided by Shao-Ping Nie, Beijing Anzhen Hospital:
anticoagulantion
post-procedure
STEMI

Additional relevant MeSH terms:
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Infarction
Myocardial Infarction
ST Elevation Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Heparin
Calcium heparin
Bivalirudin
Hirudins
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors