Status:
COMPLETED
Optimal antiPlatelet Therapy for High Bleeding and Ischemic RISK Patients Trial
Lead Sponsor:
Shenyang Northern Hospital
Conditions:
Prolonged DAPT in ACS Patients With Hisk of Both Ischemic and Hemorrhage
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
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, mult...
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 ischemi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2020
Estimated Enrollment :
7758 Patients enrolled
Trial Details
Trial ID
NCT03431142
Start Date
February 12 2018
End Date
December 30 2020
Last Update
August 21 2025
Active Locations (103)
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1
Anhui Provincial Hospital
Hefei, Anhui, China, 230001
2
The Seventh Medical Center of Pla General Hospital
Beijing, Beijing Municipality, China, 100010
3
Beijing Anzhen Hospital,Capital Medical University, word2
Beijing, Beijing Municipality, China, 100029
4
Beijing Anzhen Hospital,Capital Medical University, word3
Beijing, Beijing Municipality, China, 100029