A Phase 4 interventional study of Dual Antiplatelet (DAPT) Therapy and Rivaroxaban in ST Elevation Myocardial Infarction and No-Reflow Phenomenon, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-29.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Phase 4, Interventional, and Treatment
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.
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.
Exclusion Criteria:
DAPT (aspirin 100 mg daily plus clopidogrel 75 mg daily or ticagrelor 90 mg per dose, twice daily) for 30 consecutive days
Drug: Dual Antiplatelet (DAPT) Therapy
Rivaroxaban (2.5 mg twice daily) plus aspirin 100 mg daily plus clopidogrel 75 mg daily for 30 days
Drug: Rivaroxaban
aspirin 100 mg daily plus clopidogrel 75 mg daily or ticagrelor 90 mg per dose, twice daily for 30 consecutive days
Also known as: DAPT
Rivaroxaban (2.5 mg twice daily) plus aspirin 100 mg daily plus clopidogrel 75 mg daily for 30 days
Also known as: Rivaroxaban + Aspirin + Clopidogrel
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.
Time frame: Change from baseline within 1 week
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.
Time frame: Assessed at 7 days, 30 days, and 365 days post-Percutaneous Coronary Intervention (PCI).
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
ST Elevation Myocardial Infarction→
Second Affiliated Hospital, School of Medicine, Zhejiang University