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Rivaroxaban for Slow Coronary Flow After PCI in STEMI

ConditionsST Elevation Myocardial InfarctionNo-Reflow Phenomenon
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dual Antiplatelet (DAPT) Therapy

    Drug

    aspirin 100 mg daily plus clopidogrel 75 mg daily or ticagrelor 90 mg per dose, twice daily for 30 consecutive days

  • Rivaroxaban

    Drug

    Rivaroxaban (2.5 mg twice daily) plus aspirin 100 mg daily plus clopidogrel 75 mg daily for 30 days

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Dual Antiplatelet TherapyActive comparator 1 intervention
Group B: RivaroxabanExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

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.

Time frame
Assessed at 7 days, 30 days, and 365 days post-Percutaneous Coronary Intervention (PCI).

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Affiliated Hospital of Jiaxing University

Collaborator

The Second Affiliated Hospital of Jiaxing University

Collaborator

Wenzhou People's Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: