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

Phase 3TerminatedNCT03820466

Dr. med. Mahir Karakas68 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Acute Chest Syndrome

Interventions

AspirinDRUG

Once daily application of platelet inhibiting medication

AtorvastatinDRUG

Once daily application of lipid lowering medication

Placebo AspirinDRUG

Once daily application of placebo

Placebo Atorvastatin

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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.

Locations (7)

University of Berlin, Campus Benjamin-Franklin

Berlin, Germany

Asklepios Harz-Hospital Goslar

Goslar, Germany

University Heart Center Hamburg

Hamburg, Germany

University of Heidelberg

Heidelberg, Germany

Outcomes

Primary Outcomes

Myocardial infarction and/ or cardiovascular death and/ or revascularization

Time to myocardial infarction, coronary revascularization, or death, whatever comes first

Time frame: Until last patient has completed 12 months of follow-up

Data from ClinicalTrials.gov

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