Status:
RECRUITING
Optimize Risk Prediction After Myocardial Infarction: The ORACLE Study
Lead Sponsor:
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Collaborating Sponsors:
European Research Council
Conditions:
Myocardial Infarction (MI)
Eligibility:
All Genders
18+ years
Brief Summary
Background. Myocardial infarction (MI) is a leading cause of death worldwide. After MI, longterm antithrombotic therapy is crucial to prevent recurrent events, but increases bleeding, that also impact...
Eligibility Criteria
Inclusion
- Patients with Myocardial Infarction (i.e. hospitalization for ST- segment elevated, non-ST-segment elevated myocardial infarction or unstable angina) undergoing invasive management and at high risk of clinical events (i.e. presence of at least two of these high risk criteria: age \>65 years, diabetes mellitus, multivessel disease, peripheral artery disease, chronic kidney disease, prior stroke anytime or prior TIA in the last 6 months, prior MI, complex PCI, Prior PCI/CABG, heart failure, BMI\>27, anticipated long term use of an oral anticoagulant, haemoglobin less than 11g/dl, spontaneous bleeding requiring hospitalization or transfusion in the past 12 months, bleeding diathesis\* active malignancy other than skin, previous spontaneous intracranial hemorrhage).
- Systemic conditions associated with an increased bleeding risk (e.g. haematological disorders, including a history of or current thrombocytopaenia defined as a platelet count \<100,000/mm3 (\<100 x 10\^9/L), or any known coagulation disorder associated with increased bleeding risk.
Exclusion
- Age \< 18 years
- Low life expectancy (\<1 year)
- Pregnant or breastfeeding women
- Evidence at coronary angiography of non-significant coronary artery disease (\<30% in the left main stem or \<50% in the other coronary segments)
- Subject belongs to a vulnerable population (per investigator's judgment), subject unable to read or write, or other conditions that unable the patient to fully comprehend and comply to the study procedures as per investigator's judgement
Key Trial Info
Start Date :
June 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT06993415
Start Date
June 1 2025
End Date
February 1 2028
Last Update
June 10 2025
Active Locations (1)
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1
Hospital Universitario Virgen de la Victoria
Málaga, Málaga, Spain, 29010