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

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

Tracking Information

• First Submitted Date: February 7, 2018
• First Posted Date: February 13, 2018
• Last Update Posted Date: September 19, 2019
• Actual Study Start Date: February 12, 2018
• Estimated Primary Completion Date: January 31, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 (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 (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: Optimal antiPlatelet Therapy for High Bleeding and Ischemic RISK Patients Trial
• 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.

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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Prolonged DAPT in ACS Patients With Hisk of Both Ischemic and Hemorrhage

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 7, 2018): 7700
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 31, 2021
• Estimated Primary Completion Date: January 31, 2021 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03431142
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Han Yaling, Shenyang Northern Hospital
• Study Sponsor: Shenyang Northern Hospital
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Shenyang Northern Hospital
• Verification Date: September 2019