Status:
TERMINATED
Effect of Platelet Inhibition and / or Lipid Lowering in Non-ACS-patients With Positive Troponin
Lead Sponsor:
Dr. med. Mahir Karakas
Conditions:
Acute Chest Syndrome
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
The study evaluates the effect of platelet inhibition and / or lipid lowering in non-ACS-patients with symptoms suggestive for ACS, and elevated high-sensitivity troponin values
Detailed Description
Current databases show, that high-/ ultra sensitive (hs)/ (us) troponin levels above the 99th percentile in patients presenting with chest pain are indicative for future cardiovascular events, even wh...
Eligibility Criteria
Inclusion
- 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 high-sensitivity troponin I or T value
- Chest pain is classified as non-ACS, despite elevated hsTn (e.g. because of missing troponin dynamics)
- At least 50 years of age
Exclusion
- 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 evidence 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.
Key Trial Info
Start Date :
February 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 7 2022
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT03820466
Start Date
February 21 2020
End Date
April 7 2022
Last Update
May 24 2022
Active Locations (7)
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1
University of Berlin, Campus Benjamin-Franklin
Berlin, Germany, 12203
2
Asklepios Harz-Hospital Goslar
Goslar, Germany, 38642
3
University Heart Center Hamburg
Hamburg, Germany, 20246
4
University of Heidelberg
Heidelberg, Germany, 69120