NOAC Therapy Guided by PARIS Risk Score and D-dimer in Patients With ACS After PCI

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Acute Coronary Syndrome; Percutaneous Coronary Intervention
• Intervention / Treatment: Drug: Aspirin + Clopidogrel + Rivaroxaban; Drug: Aspirin + Clopidogrel

• Study Type: Interventional
• Enrollment (Estimated): 3944
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jinqing Yuan, MD; Phone Number: +86-10-68314466; Email: dr_jinqingyuan@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Recruiting
      • Chinese Academy of Medical Sciences, Fuwai Hospital
      • Contact: Jinqing Yuan, MD; Phone Number: +86-10-68314466; Email: dr_jinqingyuan@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 or 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Triple Antithrombotic Therapy: Aspirin (12 months) + Clopidogrel (12 months) + Rivaroxaban (3 months)	Drug: Aspirin + Clopidogrel + Rivaroxaban; Triple antithrombotic therapy: aspirin 75-100 mg orally once daily, clopidogrel 75 mg orally once daily, and rivaroxaban 2.5 mg orally twice daily; Other Names: Triple Antithrombotic Therapy
Other: Control Group; Dual Antiplatelet Therapy: Aspirin (12 months) + Clopidogrel (12 months)	Drug: Aspirin + Clopidogrel; Dual antithrombotic therapy: aspirin 75-100 mg orally once daily, clopidogrel 75 mg orally once daily; Other Names: Dual Antiplatelet Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)	Composite events including all-cause death, myocardial infarction, stroke, ischemia-driven revascularization, stent thrombosis, and systemic embolism	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause Death		12 months
Cardiac Death		12 months
Myocardial Infarction		12 months
Stroke		12 months
Ischemia-driven Revascularization		12 months
Stent Thrombosis		12 months
Systemic Embolism		12 months
Net Adverse Clinical Events	Composite events including MACCE and bleeding	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding	BARC 3,5 bleeding events	12 months

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Investigators: Principal Investigator: Jinqing Yuan, MD, Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: November 26, 2022
• First Submitted That Met QC Criteria: December 5, 2022
• First Posted (Actual): December 6, 2022

Study Record Updates

• Last Update Posted (Estimated): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 14, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; Novel Oral Anticoagulant; PARIS risk score; D-dimer; Acute Coronary Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease; Coronary Disease; Coronary Artery Disease; Syndrome; Acute Coronary Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Aspirin; Clopidogrel; Rivaroxaban
• Other Study ID Numbers: NCRC2022003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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