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

Primary Purpose

Prolonged DAPT in ACS Patients With Hisk of Both Ischemic and Hemorrhage

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Clopidogrel
Clopidogrel+aspirin
Sponsored by
Shenyang Northern Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prolonged DAPT in ACS Patients With Hisk of Both Ischemic and Hemorrhage

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • General Hospital of Shenyang Military RegionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Clopidogrel monotherapy

Clopidogrel plus aspirin

Arm Description

On the basis of 9-12 months of DAPT(aspirin+clopidogrel), continue clopidogrel monotherapy in the following 9 months.

On the basis of 9-12 months of DAPT(aspirin+clopidogrel), continue DAPT (aspirin+clopidogrel) in the following 9 months.

Outcomes

Primary Outcome Measures

Clinical relevant bleeding events
defined as BARC type 2-5 bleeding events

Secondary Outcome Measures

All bleeding events
defined all BARC type 1-5 bleeding events
Major adverse cardiovascular and cerebrovascular events(MACCE)
defined as a composite endpoints of all-cause death, myofarction, stroke and clinically indicated revascularization

Full Information

First Posted
February 7, 2018
Last Updated
October 15, 2020
Sponsor
Shenyang Northern Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03431142
Brief Title
Optimal antiPlatelet Therapy for High Bleeding and Ischemic RISK Patients Trial
Acronym
OPT-BIRISK
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 12, 2018 (Actual)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shenyang Northern Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prolonged DAPT in ACS Patients With Hisk of Both Ischemic and Hemorrhage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
7700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clopidogrel monotherapy
Arm Type
Experimental
Arm Description
On the basis of 9-12 months of DAPT(aspirin+clopidogrel), continue clopidogrel monotherapy in the following 9 months.
Arm Title
Clopidogrel plus aspirin
Arm Type
Active Comparator
Arm Description
On the basis of 9-12 months of DAPT(aspirin+clopidogrel), continue DAPT (aspirin+clopidogrel) in the following 9 months.
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
Additional 9 months of clopidogrel monotherapy after 9-12 months of DAPT (aspirin+clopidogrel)
Intervention Type
Drug
Intervention Name(s)
Clopidogrel+aspirin
Intervention Description
Additional 9 months of clopidogrel plus aspirin after 9-12 months of DAPT (aspirin+clopidogrel)
Primary Outcome Measure Information:
Title
Clinical relevant bleeding events
Description
defined as BARC type 2-5 bleeding events
Time Frame
During 9-month follow up
Secondary Outcome Measure Information:
Title
All bleeding events
Description
defined all BARC type 1-5 bleeding events
Time Frame
During 9-month follow up
Title
Major adverse cardiovascular and cerebrovascular events(MACCE)
Description
defined as a composite endpoints of all-cause death, myofarction, stroke and clinically indicated revascularization
Time Frame
During 9-month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
General Hospital of Shenyang Military Region
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110016
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Li, MD
Phone
+86-24-28897309
Email
doctorliyi@126.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32739652
Citation
Li Y, Jing Q, Wang B, Wang X, Li J, Qiao S, Chen S, Angiolillo DJ, Han Y. Extended antiplatelet therapy with clopidogrel alone versus clopidogrel plus aspirin after completion of 9- to 12-month dual antiplatelet therapy for acute coronary syndrome patients with both high bleeding and ischemic risk. Rationale and design of the OPT-BIRISK double-blinded, placebo-controlled randomized trial. Am Heart J. 2020 Oct;228:1-7. doi: 10.1016/j.ahj.2020.07.005. Epub 2020 Jul 9.
Results Reference
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Optimal antiPlatelet Therapy for High Bleeding and Ischemic RISK Patients Trial

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