Status:
UNKNOWN
Antithrombotic Therapy in Acute Coronary Syndromes and Coronary Artery Ectasia
Lead Sponsor:
Instituto Nacional de Cardiologia Ignacio Chavez
Conditions:
Acute Coronary Syndrome
Coronary Artery Ectasia
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
The optimal anti-thrombotic therapy to prevent recurrent ischemic events in patients with acute coronary syndrome and coronary artery ectasia (CAE) remains unclear. OVER-TIME is an investigator initi...
Detailed Description
Coronary artery ectasia (CAE) is defined as a segmental or diffuse abnormal dilatation that exceeds more than 1.5 times the diameter of a normal adjacent coronary segment. The prevalence of CAE ranges...
Eligibility Criteria
Inclusion
- Informed consent obtained before any trial-related activities.
- Hospitalized male or female aged \>18 years.
- First event of ACS (including both, ST- Segment Elevation or Non- ST Elevation Myocardial Infarction) with high sensitivity troponin T levels exceeding 99th percentile or segmental motion abnormalities by echocardiography.
- Angiographic evidence of CAE involving the infarction culprit artery.
- Hospital length of stay \>24 hours.
- Percutaneous revascularization or medical treatment according to the treating physician criteria.
Exclusion
- Indication for temporary or permanent anticoagulation.
- Relative or absolute contraindications to receive anticoagulation.
- Chronic kidney disease (CKD) KDIGO \> III or GFR \<30 ml/min/1.73 m2
- Angiographic evidence of coronary aneurysms (saccular or fusiform)
- Patients undergoing coronary artery bypass graft (CABG).
- Left ventricular ejection fraction \<40%.
- History of major bleeding events.
- Pregnant women.
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05233124
Start Date
September 1 2021
End Date
July 30 2024
Last Update
February 10 2022
Active Locations (2)
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1
Instituto Nacional de Cardiologia
Mexico City, Mexico, 14030
2
Instituto Nacional de Cardiología "Ignacio Chavez"
Mexico City, Mexico, 14030