Investigator-initiated, placebo-controlled, randomized trial to assess the efficacy and safety of platelet inhibition and/ or lipid lowering in non-ACS-patients with elevated high-sensitivity troponin values

Phase 3

Conditions: Subclinical myocardial ischemia

Registration Number: DRKS00017671

Lead Sponsor: niversitäres Herzzentrum Hamburg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 3000

Inclusion Criteria

• Patient with symptoms suggestive for ACS presenting within 48 hours after onset in the ER/ Chest Pain Unit (CPU)
• Patient has at least one elevated hsTn I or T value
• Symptoms are classified as non-ACS, despite elevated hsTn (e.g. because of missing troponin dynamics)
• At least 50 years of age

Exclusion Criteria

• Indication for antiplatelet therapy (e.g transient ischemic attack, or stable coronary artery diseases -CAD) or anticoagulation therapy (such as atrial fibrillation)
• Indication for anti-lipid therapy
• Any evidence of an acute myocardial necrosis (e.g imaging ev-idence of new regional wall motion abnormality, or significant ST-segment–T wave (ST–T) changes in ECG)
• Untreated clinically significant CAD requiring revascularization
• Hemoglobin value below 8 mg/d, and/or creatinine kinase =3 times ULN, and/or AST or ALT =3 times ULN
• Active malignancy of any organ system, treated or untreated. Subjects have to be in remission for at least 36 months to be eligible

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to MI (myocardial infarction), coronary revascularization, or death, whatever comes first.

Secondary Outcome Measures

Name	Time	Method
1.) The risk of the composite endpoint of first occurrence of death and MI<br>2.) The risk of the composite endpoint of first occurrence of death, MI, stroke, TIA, coronary revascularization or rehospitalization for unstable angina pectoris<br>3.) The risk of the composite endpoint of first occurrence of death, MI, or stroke<br>4.) Mortality<br>5.) Bleeding events<br>6.) Change (fold induction) in cardio-renal biomarkers from baseline to end of study visit (biomarkers will be measured in PIs core lab at end of study)<br>7.) Cancer<br>8.) Disability-free survival