NCT07195812

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
24mo left

Started Oct 2025

Typical duration for phase_4

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress23%
Oct 2025May 2028

First Submitted

Initial submission to the registry

September 17, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 29, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

2.6 years

First QC Date

September 17, 2025

Last Update Submit

September 25, 2025

Conditions

ST Elevation Myocardial InfarctionNo-Reflow Phenomenon

Keywords

RivaroxabanST Elevation Myocardial InfarctionSlow Coronary FlowNo-Reflow PhenomenonAntiplatelet TherapyPercutaneous Coronary Intervention

Outcome Measures

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.

    Change from baseline within 1 week

Secondary Outcomes (1)

  • Incidence of Major Adverse Cardiovascular Events (MACE) and bleeding events

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

Study Arms (2)

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

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

Drug: Rivaroxaban

Interventions

Dual Antiplatelet (DAPT) TherapyDRUG

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
Dual Antiplatelet Therapy
RivaroxabanDRUG

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
Rivaroxaban

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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);
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionNo-Reflow Phenomenon

Interventions

2'-deoxythymidylyl-(3'-5')-2'-deoxyadenosineTherapeuticsRivaroxabanAspirinClopidogrel

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsTiclopidineThienopyridinesPyridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Jun Jiang, Doctor

    Second Affiliated Hospital, School of Medicine, Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heyang Wang

CONTACT

86 571 87783721whysmmu@163.com

Guoyong Liu

CONTACT

283668235@qq.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2025

First Posted

September 29, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

September 29, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share