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insufficient recruitment due to the pandemic situation
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspirin | Active Comparator | Aspirin 100 mg once daily and Placebo Atorvastatin once daily |
|
| Atorvastatin | Active Comparator | Atorvastatin 20 mg once daily and Placebo Aspirin once daily |
|
| Aspirin-Atorvastatin | Experimental | Aspirin 100 mg once daily and Atorvastatin 20 mg once daily |
|
| Placebo | Placebo Comparator | Placebo Aspirin once daily and Placebo Atorvastatin once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug | Once daily application of platelet inhibiting medication |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mahir Karakas, MD | University Heart Center Hamburg | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Berlin, Campus Benjamin-Franklin | Berlin | 12203 | Germany | |||
| Asklepios Harz-Hospital Goslar |
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| ID | Term |
|---|---|
| D056586 | Acute Chest Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D000755 | Anemia, Sickle Cell |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D000069059 | Atorvastatin |
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Atorvastatin | Drug | Once daily application of lipid lowering medication |
|
|
| Placebo Aspirin | Drug | Once daily application of placebo |
|
|
| Placebo Atorvastatin | Drug | Once daily application of placebo |
|
|
| Goslar |
| 38642 |
| Germany |
| University Heart Center Hamburg | Hamburg | 20246 | Germany |
| University of Heidelberg | Heidelberg | 69120 | Germany |
| University of Leipzig | Leipzig | 04103 | Germany |
| Robert-Bosch-Hospital Stuttgart | Stuttgart | 70376 | Germany |
| University of Ulm | Ulm | 89081 | Germany |
| D000745 |
| Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004791 | Enzyme Inhibitors |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |