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Trial record 4 of 468 for:    ASPIRIN AND clopidogrel AND ischemic

Optimal antiPlatelet Therapy for High Bleeding and Ischemic RISK Patients Trial (OPT-BIRISK)

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ClinicalTrials.gov Identifier: NCT03431142
Recruitment Status : Recruiting
First Posted : February 13, 2018
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Han Yaling, Shenyang Northern Hospital

Brief Summary:

Current guidelines recommend that patients with ACS undergoing stent implantation might be offered extended DAPT treatment for up to 30 months if necessary.

Therefore, we designed a prospective, multicenter, randomized, placebo-controlled trial among ACS patients with high-risk on ischemic and bleeding who received a new generation of DES and received 9 to 12 months of DAPT, and evaluated whether clopidogrel monotherapy reduce the risk of bleeding compared with clopidogrel plus ASA in the following 9 months and achieved non-inferior outcomes in preventing ischemic risk.


Condition or disease Intervention/treatment Phase
Prolonged DAPT in ACS Patients With Hisk of Both Ischemic and Hemorrhage Drug: Clopidogrel Drug: Clopidogrel+aspirin Phase 4

Detailed Description:

Current guidelines recommend that patients with ACS undergoing stent implantation might be offered extended DAPT treatment for up to 30 months if necessary. For patients with high risk of both ischemic and hemorrhage, despite prolonged use of DAPT may bring antithrombotic benefit, it may also increase the risk of bleeding. There is an urgent need for specific guiding on intensive antiplatelet therapy in this population of patients to reduce the risk of ischemia and to avoid the risk of bleeding.

Previous studies have shown that, after 12 months of DAPT treatment, continuation of clopidogrel monotherapy may further reduce the risk of ischemia and bleeding compared with aspirin. Therefore, we designed a prospective, multicenter, randomized, placebo-controlled trial among ACS patients with high-risk on ischemic and bleeding who received a new generation of DES and received 9 to 12 months of DAPT, and evaluated whether clopidogrel monotherapy reduce the risk of bleeding compared with clopidogrel plus ASA in the following 9 months and achieved non-inferior outcomes in preventing ischemic risk.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Extended Antiplatelet Therapy With Clopidogrel Alone Versus Clopidogrel Plus Aspirin After Completion of 9- to 12-month Dual Antiplatelet Therapy for ACS Patients With Both High Bleeding and Ischemic Risk.
Actual Study Start Date : February 12, 2018
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Clopidogrel monotherapy
On the basis of 9-12 months of DAPT(aspirin+clopidogrel), continue clopidogrel monotherapy in the following 9 months.
Drug: Clopidogrel
Additional 9 months of clopidogrel monotherapy after 9-12 months of DAPT (aspirin+clopidogrel)

Active Comparator: Clopidogrel plus aspirin
On the basis of 9-12 months of DAPT(aspirin+clopidogrel), continue DAPT (aspirin+clopidogrel) in the following 9 months.
Drug: Clopidogrel+aspirin
Additional 9 months of clopidogrel plus aspirin after 9-12 months of DAPT (aspirin+clopidogrel)




Primary Outcome Measures :
  1. Clinical relevant bleeding events [ Time Frame: During 9-month follow up ]
    defined as BARC type 2-5 bleeding events


Secondary Outcome Measures :
  1. All bleeding events [ Time Frame: During 9-month follow up ]
    defined all BARC type 1-5 bleeding events

  2. Major adverse cardiovascular and cerebrovascular events(MACCE) [ Time Frame: During 9-month follow up ]
    defined as a composite endpoints of all-cause death, myofarction, stroke and clinically indicated revascularization



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ACS patients undergoing PCI (New-Generation DES) and finishing 9-12 months of DAPT
  • 18 ~ 85 years old adult patients
  • Patients under the age of 65 must meet at least one of the following clinical criteria of high bleeding risk and at least one of the following clinical criteria of high ischemic risk; Patients aged 65-75 must meet one of the following clinical criteria of either high bleeding risk or high ischemic risk.

Clinical criteria of high bleeding risk:

  • ≥75 years old
  • female
  • Iron deficiency anemia
  • history of stroke (hemorrhagic or ischemic)
  • ongoing medical treatment of diabetes (oral hypoglycemic agents or subcutaneous insulin)
  • Chronic kidney disease (eGFR <60mL/min or creatinine clearance<60mL/min)

Clinical criteria of high ischemic risk:

  • ≥75 years old
  • Multiple coronary lesions
  • target lesions required for stent of total length> 30mm
  • Thrombotic target lesions
  • Bifurcation lesions are Medina 0, 1, 1 or 1, 1, and 1, with stents implanted in both main branch and side branch
  • Left main coronary artery (≥50%) or proximal LAD (≥70%) lesions
  • Calcified plaques requiring endovascular excision
  • acute coronary syndrome with troponin positive
  • Previous myocardial infarction, ischemic stroke, diagnosed peripheral arterial disease (PAD), or revascularization due to coronary artery disease (CAD) / PAD
  • recurrent myocardial infarction, revascularization, stent thrombosis, stroke in the last 9 months
  • ongoing medical treatment of diabetes (oral hypoglycemic agents or subcutaneous insulin)
  • Chronic kidney disease (eGFR<60 mL/min or creatinine clearance <60 mL/min)

Exclusion Criteria:

  • Discontinuation or termination of DAPT treatment during the past 6 months due to adverse events (bleeding or ischemia) or other conditions
  • Surgery plan within 90 days
  • Coronary Revascularization (Surgical or Intervention) Program within 90 days
  • Dialysis-dependent renal failure
  • Moderate or severe hepatic insufficiency (2 times the upper limit of normal for ALT or AST)
  • Life expectancy <1 year
  • Unable or unwilling to provide informed consent
  • Women with childbearing potential
  • Platelet count <100000/mm3
  • Subjects undergoing warfarin or similar anticoagulant therapy

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): NCT03431142


Locations
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China, Liaoning
General Hospital of Shenyang Military Region Recruiting
Shenyang, Liaoning, China, 110016
Contact: Yi Li, MD    +86-24-28897309    doctorliyi@126.com   
Sponsors and Collaborators
Shenyang Northern Hospital

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Responsible Party: Han Yaling, Prof., Shenyang Northern Hospital
ClinicalTrials.gov Identifier: NCT03431142     History of Changes
Other Study ID Numbers: CLOPIL08732
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ischemia
Aspirin
Clopidogrel
Hemorrhage
Pathologic Processes
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents