Clinical trial NCT05638867: 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
Overall status: RECRUITING
Phase: PHASE4
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
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2022-12-06
Enrollment: 3944
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open-label, Two-arm, Randomized Superiority Trial
Primary purpose: TREATMENT

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.


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 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

Primary outcomes:
measure: Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
timeFrame: 12 months
Secondary outcomes:
measure: All-cause Death
timeFrame: 12 months
measure: Cardiac Death
timeFrame: 12 months
measure: Myocardial Infarction
timeFrame: 12 months
measure: Stroke
timeFrame: 12 months
measure: Ischemia-driven Revascularization
timeFrame: 12 months
measure: Stent Thrombosis
timeFrame: 12 months
measure: Systemic Embolism
timeFrame: 12 months
measure: Net Adverse Clinical Events
timeFrame: 12 months
Other outcomes:
measure: Bleeding
timeFrame: 12 months
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences, Fuwai Hospital
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Jinqing Yuan, MD
role: PRINCIPAL_INVESTIGATOR
References: