Effect of Platelet Inhibition and / or Lipid Lowering in Non-ACS-patients With Positive Troponin (GRAY-ZONE)

  • STATUS
    Recruiting
  • End date
    Jun 8, 2023
  • participants needed
    3000
  • sponsor
    Dr. med. Mahir Karakas
Updated on 28 February 2022

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

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 when acute coronary syndrome (ACS) was ruled out. Most of these non-ACS-patients are discharged without specific/ preventive therapy (anti-platelet or anti-lipid), although "positive" troponin values (any value at any time during hospitalisation above the 99th percentile) seem to clearly indicate underlying myocardial ischemia. In summary, there is an unmet need and huge potential to reduce mortality and morbidity in Chest Pain Unit patients by specific therapy. The investigators propose that platelet inhibition by Aspirin or lipid lowering by Atorvastatin will prevent plaque rupture and superimposition of thrombosis to coronary atherosclerosis in this population. It is planned to conduct a controlled clinical trial: 3,000 troponin positive patients presenting at emergency room (ER)/ CPU with symptoms suggestive for ACS, but an ACS was ruled out, will be assigned randomly to Aspirin 100 mg and/ or Atorvastatin 20 mg versus placebo (2x2 factorial design).

Details
Condition Acute Chest Syndrome
Treatment Atorvastatin, Aspirin, Placebo Aspirin, Placebo Atorvastatin
Clinical Study IdentifierNCT03820466
SponsorDr. med. Mahir Karakas
Last Modified on28 February 2022

Eligibility

Yes No Not Sure

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 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 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 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
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