Clinical trial NCT03820466: Effect of Platelet Inhibition and / or Lipid Lowering in Non-ACS-patients With Positive Troponin
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Acute Chest Syndrome
Keywords: Aspirin
Atorvastatin
Troponin
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2019-01-29
Enrollment: 68
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Myocardial infarction and/ or cardiovascular death and/ or revascularization
timeFrame: Until last patient has completed 12 months of follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: University of Berlin, Campus Benjamin-Franklin
city: Goslar
country: Germany
facility: Asklepios Harz-Hospital Goslar
city: Hamburg
country: Germany
facility: University Heart Center Hamburg
city: Heidelberg
country: Germany
facility: University of Heidelberg
city: Leipzig
country: Germany
facility: University of Leipzig
city: Stuttgart
country: Germany
facility: Robert-Bosch-Hospital Stuttgart
city: Ulm
country: Germany
facility: University of Ulm
Study officials:
affiliation: University Heart Center Hamburg
name: Mahir Karakas, MD
role: STUDY_CHAIR
References: