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

NCT05638867 | Recruiting Phase 4 DMC

• 1 other identifier: NCRC2022003
• Study Type: interventional
• Target: 3,944
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Percutaneous Coronary Intervention; Acute Coronary Syndrome

Keywords

Novel Oral Anticoagulant; PARIS risk score; D-dimer; Acute Coronary Syndrome; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• All-cause Death

  12 months

• Cardiac Death

  12 months

• Myocardial Infarction

  12 months

• Stroke

  12 months

• Ischemia-driven Revascularization

  12 months

Other Outcomes (1)

• Bleeding

  12 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

Triple Antithrombotic Therapy: Aspirin (12 months) + Clopidogrel (12 months) + Rivaroxaban (3 months)

Drug: Aspirin + Clopidogrel + Rivaroxaban

Control Group

OTHER

Dual Antiplatelet Therapy: Aspirin (12 months) + Clopidogrel (12 months)

Drug: Aspirin + Clopidogrel

Interventions

Aspirin + Clopidogrel + Rivaroxaban DRUG

Triple antithrombotic therapy: aspirin 75-100 mg orally once daily, clopidogrel 75 mg orally once daily, and rivaroxaban 2.5 mg orally twice daily

Also known as: Triple Antithrombotic Therapy

Experimental Group

Aspirin + Clopidogrel DRUG

Dual antithrombotic therapy: aspirin 75-100 mg orally once daily, clopidogrel 75 mg orally once daily

Also known as: Dual Antiplatelet Therapy

Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Chinese Academy of Medical Sciences, Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

RECRUITING

Related Publications (1)

• Jia S, Song Y, Yuan D, Wang P, Xu J, Chen Y, Zhang C, Zhao X, Yuan JQ. 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 protocol for the PRIDE-ACS trial. BMJ Open. 2025 May 15;15(5):e090126. doi: 10.1136/bmjopen-2024-090126.

  PMID: 40379336 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Acute Coronary Syndrome

Interventions

Aspirin; Clopidogrel; Rivaroxaban

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Morpholines; Oxazines

Study Officials

• Jinqing Yuan, MD

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinqing Yuan, MD

CONTACT

+86-10-68314466; dr_jinqingyuan@sina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is an open-label study. But while the study is in progress, the grouping information is masked from outcome assessors (CEC).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of Coronary Heart Disease Center, Director of Ward 1

Model Details: Open-label, Two-arm, Randomized Superiority Trial

Study Record Dates

• First Submitted: November 26, 2022
• First Posted: December 6, 2022
• Study Start: November 25, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 17, 2024

Record last verified: 2024-01

Locations

CN (1)