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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05638867
• Other study ID #: NCRC2022003
• Status: Recruiting
• Phase: Phase 4
• Start date: November 25, 2023
• Est. completion date: January 2027

Study information

• Verified date: January 2024
• Source: China National Center for Cardiovascular Diseases
• Contact: Jinqing Yuan, MD
• Phone: +86-10-68314466
• Email: dr_jinqingyuan[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3944
• Est. completion date: January 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Percutaneous Coronary Intervention
• Syndrome

Intervention

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
• Aspirin + Clopidogrel
Dual antithrombotic therapy: aspirin 75-100 mg orally once daily, clopidogrel 75 mg orally once daily

Locations

Country	Name	City	State
China	Chinese Academy of Medical Sciences, Fuwai Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bleeding	BARC 3,5 bleeding events	12 months
Primary	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	All-cause Death		12 months
Secondary	Cardiac Death		12 months
Secondary	Myocardial Infarction		12 months
Secondary	Stroke		12 months
Secondary	Ischemia-driven Revascularization		12 months
Secondary	Stent Thrombosis		12 months
Secondary	Systemic Embolism		12 months
Secondary	Net Adverse Clinical Events	Composite events including MACCE and bleeding	12 months