NOAC Therapy Guided by PARIS Risk Score and D-dimer in Patients With ACS After PCI
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChina National Center for Cardiovascular Diseases
About this trial
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
Qualifiers
Diagnosed with Acute Coronary Syndrome 1-7 days after initial symptom stabilization,
Aged 18-75 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,
Disqualifiers
Platelet level below 90 x10^6
Hemoglobin level is less than 11g/dL
History of severe bleeding
History of stroke/TIA
Trial design
Treatments tested in this trial
- Aspirin + Clopidogrel + Rivaroxaban
- Aspirin + Clopidogrel
Treatment groups
3,944 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov