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

Study Overview
=================
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).

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

Conditions
-----------------
Acute Chest Syndrome

Intervention / Treatment
-----------------
* Drug: Aspirin
* Drug: Atorvastatin
* Drug: Placebo Aspirin
* Drug: Placebo Atorvastatin


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aspirin<br>Aspirin 100 mg once daily and Placebo Atorvastatin once daily | Drug: Aspirin<br>* Once daily application of platelet inhibiting medication<br>* Other names: Acetyl Salicyl Acid;Drug: Placebo Atorvastatin<br>* Once daily application of placebo<br>* Other names: Placebo Oral Tablet;|
| Active Comparator: Atorvastatin<br>Atorvastatin 20 mg once daily and Placebo Aspirin once daily | Drug: Atorvastatin<br>* Once daily application of lipid lowering medication<br>* Other names: Statin;Drug: Placebo Aspirin<br>* Once daily application of placebo<br>* Other names: Placebo Oral Tablet;|
| Experimental: Aspirin-Atorvastatin<br>Aspirin 100 mg once daily and Atorvastatin 20 mg once daily | Drug: Aspirin<br>* Once daily application of platelet inhibiting medication<br>* Other names: Acetyl Salicyl Acid;Drug: Atorvastatin<br>* Once daily application of lipid lowering medication<br>* Other names: Statin;|
| Placebo Comparator: Placebo<br>Placebo Aspirin once daily and Placebo Atorvastatin once daily | Drug: Placebo Aspirin<br>* Once daily application of placebo<br>* Other names: Placebo Oral Tablet;Drug: Placebo Atorvastatin<br>* Once daily application of placebo<br>* Other names: Placebo Oral Tablet;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial infarction and/ or cardiovascular death and/ or revascularization | Time to myocardial infarction, coronary revascularization, or death, whatever comes first | Until last patient has completed 12 months of follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aspirin, Atorvastatin, Troponin