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Trial record 4 of 469 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

Tracking Information
First Submitted Date  ICMJE February 7, 2018
First Posted Date  ICMJE February 13, 2018
Last Update Posted Date September 19, 2019
Actual Study Start Date  ICMJE February 12, 2018
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2018)
Clinical relevant bleeding events [ Time Frame: During 9-month follow up ]
defined as BARC type 2-5 bleeding events
Original Primary Outcome Measures  ICMJE
 (submitted: February 7, 2018)
Clinical bleeding events [ Time Frame: During 9-month follow up ]
BARC2-5 bleeding events
Change History Complete list of historical versions of study NCT03431142 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2018)
  • All bleeding events [ Time Frame: During 9-month follow up ]
    defined all BARC type 1-5 bleeding events
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2018)
  • All bleeding [ Time Frame: During 9-month follow up ]
    BARC1-5 bleeding events
  • Major adverse cardiovascular and cerebrovascular events(MACCE) [ Time Frame: During 9-month follow up ]
    compasite endpoints of all-cause death, myofarction, stroke and clinically indicated revascularization
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimal antiPlatelet Therapy for High Bleeding and Ischemic RISK Patients Trial
Official Title  ICMJE 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.
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Prolonged DAPT in ACS Patients With Hisk of Both Ischemic and Hemorrhage
Intervention  ICMJE
  • Drug: Clopidogrel
    Additional 9 months of clopidogrel monotherapy after 9-12 months of DAPT (aspirin+clopidogrel)
  • Drug: Clopidogrel+aspirin
    Additional 9 months of clopidogrel plus aspirin after 9-12 months of DAPT (aspirin+clopidogrel)
Study Arms  ICMJE
  • Experimental: Clopidogrel monotherapy
    On the basis of 9-12 months of DAPT(aspirin+clopidogrel), continue clopidogrel monotherapy in the following 9 months.
    Intervention: Drug: 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.
    Intervention: Drug: Clopidogrel+aspirin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 7, 2018)
7700
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2021
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03431142
Other Study ID Numbers  ICMJE CLOPIL08732
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Han Yaling, Shenyang Northern Hospital
Study Sponsor  ICMJE Shenyang Northern Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shenyang Northern Hospital
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP