Coronary Artery DiseasePhase 4NCT05638867
NOAC Therapy Guided by PARIS Risk Score and D-dimer in Patients With ACS After PCI
A Phase 4 study testing Aspirin + Clopidogrel + Rivaroxaban and Aspirin + Clopidogrel in people with Coronary Artery Disease and Percutaneous Coronary Intervention, run by China National Center for Cardiovascular Diseases at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease, Percutaneous Coronary Intervention, Acute Coronary Syndrome
- What is being tested?
- Aspirin + Clopidogrel + Rivaroxaban and Aspirin + Clopidogrel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,944 participants
- Where
- 1 siteChina
- Study dates
- 25 Nov 2023to Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Medical Sciences, Fuwai Hospital
Beijing, Beijing Municipality, 100037
Jinqing Yuan, MD, +86-10-68314466, dr_jinqingyuan@sina.com
About this study
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
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.
- Being tested
- Aspirin + Clopidogrel + Rivaroxaban, Aspirin + Clopidogrel
- Keywords
- Novel Oral Anticoagulant, PARIS risk score, D-dimer, Acute Coronary Syndrome, Percutaneous Coronary Intervention
- Medical subject headings
- Coronary Artery Disease, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin + Clopidogrel + RivaroxabanDrug
Also called Triple Antithrombotic Therapy
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 + ClopidogrelDrug
Also called Dual Antiplatelet Therapy
Dual antithrombotic therapy: aspirin 75-100 mg orally once daily, clopidogrel 75 mg orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Triple Antithrombotic Therapy: Aspirin (12 months) + Clopidogrel (12 months) + Rivaroxaban (3 months) Receives: Drug: Aspirin + Clopidogrel + Rivaroxaban |
| Control Group | Other | Dual Antiplatelet Therapy: Aspirin (12 months) + Clopidogrel (12 months) Receives: Drug: Aspirin + Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Composite events including all-cause death, myocardial infarction, stroke, ischemia-driven revascularization, stent thrombosis, and systemic embolism
Measured: 12 months
Secondary outcomes (8)
All-cause Death
Measured: 12 months
Cardiac Death
Measured: 12 months
Myocardial Infarction
Measured: 12 months
Stroke
Measured: 12 months
Ischemia-driven Revascularization
Measured: 12 months
Stent Thrombosis
Measured: 12 months
Systemic Embolism
Measured: 12 months
Net Adverse Clinical Events
Composite events including MACCE and bleeding
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start25 Nov 2023
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, Two-arm, Randomized Superiority Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,944 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jinqing Yuan, China National Center for Cardiovascular Diseases
- Investigators
- Jinqing Yuan, MD, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638867
- Sponsor's protocol ID
- NCRC2022003
- Status last verified
- Aug 2026
- First submitted
- 26 Nov 2022
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40379336
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05638867
- Acronym / sponsor ID
- NCRC2022003
- Keywords
- Novel Oral Anticoagulant, PARIS risk score, D-dimer, Acute Coronary Syndrome, Percutaneous Coronary Intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,944 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 25 Nov 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Open-label, Two-arm, Randomized Superiority Trial
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: Aspirin + Clopidogrel + RivaroxabanTriple Antithrombotic Therapy: Aspirin (12 months) + Clopidogrel (12 months) + Rivaroxaban (3 months) |
| Control Group | Other | Drug: Aspirin + ClopidogrelDual Antiplatelet Therapy: Aspirin (12 months) + Clopidogrel (12 months) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin + Clopidogrel + RivaroxabanAlso: Triple Antithrombotic TherapyTriple antithrombotic therapy: aspirin 75-100 mg orally once daily, clopidogrel 75 mg orally once daily, and rivaroxaban 2.5 mg orally twice daily | Drug | Experimental Group |
| Aspirin + ClopidogrelAlso: Dual Antiplatelet TherapyDual antithrombotic therapy: aspirin 75-100 mg orally once daily, clopidogrel 75 mg orally once daily | Drug | Control Group |
Primary outcome
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Time frame: 12 months
Composite events including all-cause death, myocardial infarction, stroke, ischemia-driven revascularization, stent thrombosis, and systemic embolism
8 secondary outcomes
All-cause Death
Time frame: 12 months
Cardiac Death
Time frame: 12 months
Myocardial Infarction
Time frame: 12 months
Stroke
Time frame: 12 months
Ischemia-driven Revascularization
Time frame: 12 months
Stent Thrombosis
Time frame: 12 months
Systemic Embolism
Time frame: 12 months
Net Adverse Clinical Events
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Derived from this study: PubMed 40379336Jia 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.
- Individual participant dataSharing planned: Undecided
Related trials for Coronary Artery Disease
Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)
Active, not recruitingPhase 3
Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events
Coronary Artery Disease
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Active, not recruiting
Troponin in Acute Chest Pain to Risk Stratify and Guide EffecTive Use of Computed Tomography Coronary Angiography
Coronary Artery Disease
Recruiting
A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium (The Optimal Trial)
Cardiovascular Diseases, Myocardial Ischemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jinqing Yuan, MD principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin + Clopidogrel + Rivaroxaban and Aspirin + Clopidogrel in people with Coronary Artery Disease and Percutaneous Coronary Intervention, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jinqing Yuan, MD (+86-10-68314466, dr_jinqingyuan@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05638867, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.