Back to resultsNOAC Therapy Guided by PARIS Risk Score and D-dimer in Patients With ACS After PCI
Primary Purpose
Coronary Artery Disease, Percutaneous Coronary Intervention, Acute Coronary Syndrome
Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Aspirin + Clopidogrel + Rivaroxaban
Aspirin + Clopidogrel
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Novel Oral Anticoagulant, PARIS risk score, D-dimer, Acute Coronary Syndrome, Percutaneous Coronary Intervention
Eligibility Criteria
Inclusion Criteria: Diagnosed with Acute Coronary Syndrome 1-7 days after initial symptom stabilization, Aged 18-65 years old, Elevated D-dimer levels (≥0.28 μg/ml) on admission, PARIS coronary thrombosis risk score ≥ 3 points, Received Percutaneous Coronary Intervention and not on non-oral anticoagulants, Indicated for dual antiplatelet medication Exclusion Criteria: Platelet level below 90 x10^6 Hemoglobin level is less than 11g/dL History of severe bleeding History of stroke/TIA Severe hepatic/renal insufficiency Indicated for anticoagulation
Sites / Locations
- Chinese Academy of Medical Sciences, Fuwai Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Experimental Group
Control Group
Arm Description
Triple Antithrombotic Therapy: Aspirin (12 months) + Clopidogrel (12 months) + Rivaroxaban (3 months)
Dual Antiplatelet Therapy: Aspirin (12 months) + Clopidogrel (12 months)
Outcomes
Primary Outcome Measures
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Composite events including all-cause death, myocardial infarction, stroke, ischemia-driven revascularization, stent thrombosis, and systemic embolism
Secondary Outcome Measures
All-cause Death
Cardiac Death
Myocardial Infarction
Stroke
Ischemia-driven Revascularization
Stent Thrombosis
Systemic Embolism
Net Adverse Clinical Events
Composite events including MACCE and bleeding
Full Information
NCT ID
NCT05638867
First Posted
November 26, 2022
Last Updated
June 6, 2023
Sponsor
China National Center for Cardiovascular Diseases
1. Study Identification
Unique Protocol Identification Number
NCT05638867
Brief Title
NOAC Therapy Guided by PARIS Risk Score and D-dimer in Patients With ACS After PCI
Official Title
A Randomized Controlled Clinical Trial of PARIS Coronary Thrombosis Risk Score Combined With D-dimer to Guide New Oral Anticoagulant Antithrombotic Therapy in Patients With Acute Coronary Syndrome After Percutaneous Coronary Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
January 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China National Center for Cardiovascular Diseases
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of this clinical trial is to compare short-term Triple Antithrombotic Therapy (DAPT + Rivaroxaban) followed by DAPT with standard DAPT in selected ACS patients with high ischemic risk. The main questions it aims to answer are:
Whether the intervention is effective in reducing ischemic events
Whether the intervention is safe from increasing bleeding events, especially severe or fatal ones
Participants will be randomized to receive standard DAPT therapy for the entire study duration or low-dose rivaroxaban+DAPT for 3 months, followed by standard DAPT for the rest of the study duration. Patients enrolled should complete 5 follow-ups in the form of clinic visit or telephone call.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Percutaneous Coronary Intervention, Acute Coronary Syndrome
Keywords
Novel Oral Anticoagulant, PARIS risk score, D-dimer, Acute Coronary Syndrome, Percutaneous Coronary Intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Open-label, Two-arm, Randomized Superiority Trial
Masking
Outcomes Assessor
Masking Description
This is an open-label study. But while the study is in progress, the grouping information is masked from outcome assessors (CEC).
Allocation
Randomized
Enrollment
3944 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Triple Antithrombotic Therapy: Aspirin (12 months) + Clopidogrel (12 months) + Rivaroxaban (3 months)
Arm Title
Control Group
Arm Type
Other
Arm Description
Dual Antiplatelet Therapy: Aspirin (12 months) + Clopidogrel (12 months)
Intervention Type
Drug
Intervention Name(s)
Aspirin + Clopidogrel + Rivaroxaban
Other Intervention Name(s)
Triple Antithrombotic Therapy
Intervention Description
Triple antithrombotic therapy: aspirin 75-100 mg orally once daily, clopidogrel 75 mg orally once daily, and rivaroxaban 2.5 mg orally twice daily
Intervention Type
Drug
Intervention Name(s)
Aspirin + Clopidogrel
Other Intervention Name(s)
Dual Antiplatelet Therapy
Intervention Description
Dual antithrombotic therapy: aspirin 75-100 mg orally once daily, clopidogrel 75 mg orally once daily
Primary Outcome Measure Information:
Title
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Description
Composite events including all-cause death, myocardial infarction, stroke, ischemia-driven revascularization, stent thrombosis, and systemic embolism
Time Frame
12 months
Secondary Outcome Measure Information:
Title
All-cause Death
Time Frame
12 months
Title
Cardiac Death
Time Frame
12 months
Title
Myocardial Infarction
Time Frame
12 months
Title
Stroke
Time Frame
12 months
Title
Ischemia-driven Revascularization
Time Frame
12 months
Title
Stent Thrombosis
Time Frame
12 months
Title
Systemic Embolism
Time Frame
12 months
Title
Net Adverse Clinical Events
Description
Composite events including MACCE and bleeding
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Bleeding
Description
BARC 3,5 bleeding events
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with Acute Coronary Syndrome 1-7 days after initial symptom stabilization,
Aged 18-65 years old,
Elevated D-dimer levels (≥0.28 μg/ml) on admission,
PARIS coronary thrombosis risk score ≥ 3 points,
Received Percutaneous Coronary Intervention and not on non-oral anticoagulants,
Indicated for dual antiplatelet medication
Exclusion Criteria:
Platelet level below 90 x10^6
Hemoglobin level is less than 11g/dL
History of severe bleeding
History of stroke/TIA
Severe hepatic/renal insufficiency
Indicated for anticoagulation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jinqing Yuan, MD
Phone
+86-10-68314466
Email
dr_jinqingyuan@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinqing Yuan, MD
Organizational Affiliation
Chinese Academy of Medical Sciences, Fuwai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese Academy of Medical Sciences, Fuwai Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinqing Yuan, MD
Phone
+86-10-68314466
Email
dr_jinqingyuan@sina.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
NOAC Therapy Guided by PARIS Risk Score and D-dimer in Patients With ACS After PCI
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