NCT03820466

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Dr. med. Mahir Karakas · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Acute Chest Syndrome

Interventions

Type	Name	Description
DRUG	Aspirin	Once daily application of platelet inhibiting medication
DRUG	Atorvastatin	Once daily application of lipid lowering medication
DRUG	Placebo Aspirin	Once daily application of placebo
DRUG	Placebo Atorvastatin	Once daily application of placebo

Timeline

• Start date: 2020-02-21
• Primary completion: 2021-12-02
• Completion: 2022-04-07
• First posted: 2019-01-29
• Last updated: 2022-05-24

Locations

7 sites across 1 country: Germany