RecruitingPhase 4

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

China3,944 participantsStarted 2023-11-25

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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, * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)

Timeframe: 12 months

Trial details

NCT IDNCT05638867

SponsorChina National Center for Cardiovascular Diseases

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Jinqing Yuan, MD

+86-10-68314466 dr_jinqingyuan@sina.com

View on ClinicalTrials.gov More Coronary Artery Disease trials