ST Elevation Myocardial InfarctionPhase 4NCT07195812
Rivaroxaban for Slow Coronary Flow After PCI in STEMI
A Phase 4 study testing Dual Antiplatelet (DAPT) Therapy and Rivaroxaban in people with ST Elevation Myocardial Infarction and No-Reflow Phenomenon, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
The goal of this clinical trial is to learn if drug Rivaroxaban works to improve slow flow in STEMI patients after PCI in adults. It will also learn about the safety of drug Rivaroxaban. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Elevation Myocardial Infarction, No-Reflow Phenomenon
- What is being tested?
- Dual Antiplatelet (DAPT) Therapy and Rivaroxaban
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to May 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years, regardless of gender;
- Patients with ST-segment elevation myocardial infarction (STEMI) (meeting the diagnostic criteria of the 2019 Chinese "Guidelines for the Diagnosis and Treatment of Acute ST-Segment Elevation Myocardial Infarction");
- Patients undergoing percutaneous coronary intervention (PCI);
- Patients with slow flow after PCI (TIMI flow grade > 0 but < 3);
- Signed informed consent form and willingness to comply with follow-up.
Who cannot join
- Presence of malignant tumors or diseases with a life expectancy of less than 1 year;
- Coagulation disorders, diagnosed or suspected hematological diseases (excluding mild or moderate anemia);
- Thrombocytopenia (platelet count < 100 × 10⁹/L); history of severe gastrointestinal diseases or peptic ulcers; active bleeding within the past 3 months or major surgery history; history of intracranial hemorrhage or intracranial aneurysm;
- History of cerebral hemorrhage or ischemic stroke within the past 6 months;
- Patients with cardiogenic shock; systemic infections or immune system diseases; confirmed, highly suspected, or unable to rule out aortic dissection; severe uncontrolled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 110 mmHg);
- Current use of rivaroxaban or requiring long-term anticoagulation therapy (e.g., atrial fibrillation);
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- Patients with renal insufficiency (eGFR < 15 mL/min/1.73m²) or hepatic insufficiency (Child-Pugh Class B or C);
- Lactating or pregnant women, or women of childbearing potential unable to use effective contraception during the study period;
- Patients with any contraindications or allergies to rivaroxaban, aspirin, clopidogrel, or ticagrelor;
- Participation in other clinical trials within the past 3 months;
- Other conditions deemed unsuitable for participation by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Guoyong Liu contact
About this study
Official title: Evaluation of the Efficacy and Safety of Rivaroxaban in Improving Slow Coronary Flow After Percutaneous Coronary Intervention in STEMI Patients: A Multicenter, Prospective,Randomized, Controlled Study
The goal of this clinical trial is to learn if drug Rivaroxaban works to improve slow flow in STEMI patients after PCI in adults. It will also learn about the safety of drug Rivaroxaban. The main questions it aims to answer are:
Does drug Rivaroxaban Reduce the Corrected TIMI Frame Count (cTFC) in 1 Week After PCI ?
Read more
Researchers will compare Combination therapy with rivaroxaban (2.5 mg administered twice daily), aspirin (100 mg administered daily), and clopidogrel (75 mg administered daily) to Dual Antiplatelet Therapy to see if drug Combination therapy with rivaroxaban, aspirin works to treat Slow Flow in STEMI Patients After PCI.
Participants will:
Take drug Combination therapy with rivaroxaban (2.5 mg administered twice daily), aspirin (100 mg administered daily), and clopidogrel (75 mg administered daily) or Dual Antiplatelet Therapy every day for 1 months.
Visit the clinic in 7 days、30 days and 365 days for checkups and tests.
Read the detailed description
The trial is a multicenter, prospective, randomized, open-label, controlled, pilot trial evaluating the efficacy and safety of rivaroxaban for improving slow coronary flow in ST-segment elevation myocardial infarction (STEMI) patients after percutaneous coronary intervention (PCI). Patients with STEMI who have undergone PCI and exhibit slow coronary flow (TIMI flow grade >0，and < 3, ) are eligible for the clinical trial. Slow coronary flow will be quantitatively assessed using the corrected TIMI frame count (cTFC) method.
The study consists of two parallel treatment groups, evaluating the clinical efficacy and safety of 30 days of combination antithrombotic therapy versus standard therapy, followed up to 365 days. The treatment groups are:
Group 1 - Experimental Antithrombotic Therapy Eligible patients will receive a combination of rivaroxaban (2.5 mg orally twice daily) plus dual antiplatelet therapy (DAPT: aspirin 100 mg/day and clopidogrel 75 mg/day) for a total duration of 30 days (treatment period), followed by assessments at 7 days, 30 days, and 365 days (follow-up period).
Group 2 - Standard Antithrombotic Therapy (Control) Eligible patients will receive standard DAPT (aspirin 100 mg/day and clopidogrel 75 mg/day or ticagrelor 90 mg twice daily) for a total duration of 30 days (treatment period), followed by assessments at 7 days, 30 days, and 365 days (follow-up period).
The primary efficacy endpoint is the change in cTFC from baseline to within 1 week after PCI. Key secondary endpoints include the incidence of Major Adverse Cardiovascular Events (MACE) and bleeding events (assessed by BARC criteria) at 7 days, 30 days, and 365 days.
- Being tested
- Dual Antiplatelet (DAPT) Therapy, Rivaroxaban
- Keywords
- Rivaroxaban, ST Elevation Myocardial Infarction, Slow Coronary Flow, No-Reflow Phenomenon, Antiplatelet Therapy, Percutaneous Coronary Intervention
- Medical subject headings
- ST Elevation Myocardial Infarction, No-Reflow Phenomenon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual Antiplatelet (DAPT) TherapyDrug
Also called DAPT
aspirin 100 mg daily plus clopidogrel 75 mg daily or ticagrelor 90 mg per dose, twice daily for 30 consecutive days
RivaroxabanDrug
Also called Rivaroxaban + Aspirin + Clopidogrel
Rivaroxaban (2.5 mg twice daily) plus aspirin 100 mg daily plus clopidogrel 75 mg daily for 30 days
| Study group | Role | What they receive |
|---|---|---|
| Dual Antiplatelet Therapy | Active comparator | DAPT (aspirin 100 mg daily plus clopidogrel 75 mg daily or ticagrelor 90 mg per dose, twice daily) for 30 consecutive days Receives: Drug: Dual Antiplatelet (DAPT) Therapy |
| Rivaroxaban | Experimental | Rivaroxaban (2.5 mg twice daily) plus aspirin 100 mg daily plus clopidogrel 75 mg daily for 30 days Receives: Drug: Rivaroxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Corrected TIMI Frame Count (cTFC) from baseline within 1 week after PCI
Angiographic image acquisition should be standardized to a frame rate of 30 frames per second (fps). The TIMI frame count is calculated by determining the number of frames required for the contrast agent to travel from the initial opacification of the vessel to a standardized distal landmark. The designated distal landmarks vary depending on the coronary artery branch: for the left anterior descending artery (LAD), it is the distal bifurcation; for the left circumflex artery (LCx), it is the most distal branch of the obtuse marginal artery; and for the right coronary artery (RCA), it is the first branch of the posterolateral artery. Due to the longer length of the LAD compared to the LCx and RCA, the frame count for the LAD is divided by 1.7 to correct for this difference. The resulting value is the cTFC.
Measured: Change from baseline within 1 week
Secondary outcomes (1)
Incidence of Major Adverse Cardiovascular Events (MACE) and bleeding events
The incidence of Major Adverse Cardiovascular Events (MACE), defined as a composite of Non-fatal myocardial infarction, cardiac death, stroke, target vessel revascularization, and stent thrombosis, and the incidence of bleeding events, classified according to the Bleeding Academic Research Consortium (BARC) criteria.
Measured: Assessed at 7 days, 30 days, and 365 days post-Percutaneous Coronary Intervention (PCI).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study startOct 2025 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Hospital of Jiaxing University, The Second Affiliated Hospital of Jiaxing University, Wenzhou People's Hospital
- Responsible party
- Sponsor
- Investigators
- Jun Jiang, Doctor, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195812
- Sponsor's protocol ID
- 20251206
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Rivaroxaban in Improving Slow Coronary Flow After Percutaneous Coronary Intervention in STEMI Patients: A Multicenter, Prospective,Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT07195812
- Acronym / sponsor ID
- 20251206
- Keywords
- Rivaroxaban, ST Elevation Myocardial Infarction, Slow Coronary Flow, No-Reflow Phenomenon, Antiplatelet Therapy, Percutaneous Coronary Intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Affiliated Hospital of Jiaxing University, The Second Affiliated Hospital of Jiaxing University, Wenzhou People's Hospital
- Study start
- Oct 2025 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 29 Sep 2025 (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 learn if drug Rivaroxaban works to improve slow flow in STEMI patients after PCI in adults. It will also learn about the safety of drug Rivaroxaban. The main questions it aims to answer are:
Does drug Rivaroxaban Reduce the Corrected TIMI Frame Count (cTFC) in 1 Week After PCI ?
Researchers will compare Combination therapy with rivaroxaban (2.5 mg administered twice daily), aspirin (100 mg administered daily), and clopidogrel (75 mg administered daily) to Dual Antiplatelet Therapy to see if drug Combination therapy with rivaroxaban, aspirin works to treat Slow Flow in STEMI Patients After PCI.
Participants will:
Take drug Combination therapy with rivaroxaban (2.5 mg administered twice daily), aspirin (100 mg administered daily), and clopidogrel (75 mg administered daily) or Dual Antiplatelet Therapy every day for 1 months.
Visit the clinic in 7 days、30 days and 365 days for checkups and tests.
Detailed description
The trial is a multicenter, prospective, randomized, open-label, controlled, pilot trial evaluating the efficacy and safety of rivaroxaban for improving slow coronary flow in ST-segment elevation myocardial infarction (STEMI) patients after percutaneous coronary intervention (PCI). Patients with STEMI who have undergone PCI and exhibit slow coronary flow (TIMI flow grade >0，and < 3, ) are eligible for the clinical trial. Slow coronary flow will be quantitatively assessed using the corrected TIMI frame count (cTFC) method.
The study consists of two parallel treatment groups, evaluating the clinical efficacy and safety of 30 days of combination antithrombotic therapy versus standard therapy, followed up to 365 days. The treatment groups are:
Group 1 - Experimental Antithrombotic Therapy Eligible patients will receive a combination of rivaroxaban (2.5 mg orally twice daily) plus dual antiplatelet therapy (DAPT: aspirin 100 mg/day and clopidogrel 75 mg/day) for a total duration of 30 days (treatment period), followed by assessments at 7 days, 30 days, and 365 days (follow-up period).
Group 2 - Standard Antithrombotic Therapy (Control) Eligible patients will receive standard DAPT (aspirin 100 mg/day and clopidogrel 75 mg/day or ticagrelor 90 mg twice daily) for a total duration of 30 days (treatment period), followed by assessments at 7 days, 30 days, and 365 days (follow-up period).
The primary efficacy endpoint is the change in cTFC from baseline to within 1 week after PCI. Key secondary endpoints include the incidence of Major Adverse Cardiovascular Events (MACE) and bleeding events (assessed by BARC criteria) at 7 days, 30 days, and 365 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual Antiplatelet Therapy | Active comparator | Drug: Dual Antiplatelet (DAPT) TherapyDAPT (aspirin 100 mg daily plus clopidogrel 75 mg daily or ticagrelor 90 mg per dose, twice daily) for 30 consecutive days |
| Rivaroxaban | Experimental | Drug: RivaroxabanRivaroxaban (2.5 mg twice daily) plus aspirin 100 mg daily plus clopidogrel 75 mg daily for 30 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years, regardless of gender;
- Patients with ST-segment elevation myocardial infarction (STEMI) (meeting the diagnostic criteria of the 2019 Chinese "Guidelines for the Diagnosis and Treatment of Acute ST-Segment Elevation Myocardial Infarction");
- Patients undergoing percutaneous coronary intervention (PCI);
- Patients with slow flow after PCI (TIMI flow grade > 0 but < 3);
- Signed informed consent form and willingness to comply with follow-up.
Key exclusion criteria (11 listed)
- Presence of malignant tumors or diseases with a life expectancy of less than 1 year;
- Coagulation disorders, diagnosed or suspected hematological diseases (excluding mild or moderate anemia);
- Thrombocytopenia (platelet count < 100 × 10⁹/L); history of severe gastrointestinal diseases or peptic ulcers; active bleeding within the past 3 months or major surgery history; history of intracranial hemorrhage or intracranial aneurysm;
- History of cerebral hemorrhage or ischemic stroke within the past 6 months;
- Patients with cardiogenic shock; systemic infections or immune system diseases; confirmed, highly suspected, or unable to rule out aortic dissection; severe uncontrolled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 110 mmHg);
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 |
|---|---|---|
| Dual Antiplatelet (DAPT) TherapyAlso: DAPTaspirin 100 mg daily plus clopidogrel 75 mg daily or ticagrelor 90 mg per dose, twice daily for 30 consecutive days | Drug | Dual Antiplatelet Therapy |
| RivaroxabanAlso: Rivaroxaban + Aspirin + ClopidogrelRivaroxaban (2.5 mg twice daily) plus aspirin 100 mg daily plus clopidogrel 75 mg daily for 30 days | Drug | Rivaroxaban |
Primary outcome
Change in Corrected TIMI Frame Count (cTFC) from baseline within 1 week after PCI
Time frame: Change from baseline within 1 week
Angiographic image acquisition should be standardized to a frame rate of 30 frames per second (fps). The TIMI frame count is calculated by determining the number of frames required for the contrast agent to travel from the initial opacification of the vessel to a standardized distal landmark. The designated distal landmarks vary depending on the coronary artery branch: for the left anterior descending artery (LAD), it is the distal bifurcation; for the left circumflex artery (LCx), it is the most distal branch of the obtuse marginal artery; and for the right coronary artery (RCA), it is the first branch of the posterolateral artery. Due to the longer length of the LAD compared to the LCx and RCA, the frame count for the LAD is divided by 1.7 to correct for this difference. The resulting value is the cTFC.
1 secondary outcome
Incidence of Major Adverse Cardiovascular Events (MACE) and bleeding events
Time frame: Assessed at 7 days, 30 days, and 365 days post-Percutaneous Coronary Intervention (PCI).
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 29 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Guoyong Liu contact
Jun Jiang, Doctor principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dual Antiplatelet (DAPT) Therapy and Rivaroxaban in people with ST Elevation Myocardial Infarction and No-Reflow Phenomenon, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 11 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: opening soon, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Heyang Wang (86 571 87783721, whysmmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Corrected TIMI Frame Count (cTFC) from baseline within 1 week after PCI (time frame: Change from baseline within 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2025.