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

NCT ID: NCT03820466

Last Updated: 2022-05-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-21
• Study Completion Date: 2022-04-07

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).

Conditions

Acute Chest Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Aspirin

Aspirin 100 mg once daily and Placebo Atorvastatin once daily

Group Type: ACTIVE_COMPARATOR

Aspirin

Intervention Type: DRUG

Once daily application of platelet inhibiting medication

Placebo Atorvastatin

Intervention Type: DRUG

Once daily application of placebo

Atorvastatin

Atorvastatin 20 mg once daily and Placebo Aspirin once daily

Group Type: ACTIVE_COMPARATOR

Atorvastatin

Intervention Type: DRUG

Once daily application of lipid lowering medication

Placebo Aspirin

Intervention Type: DRUG

Once daily application of placebo

Aspirin-Atorvastatin

Aspirin 100 mg once daily and Atorvastatin 20 mg once daily

Group Type: EXPERIMENTAL

Aspirin

Intervention Type: DRUG

Once daily application of platelet inhibiting medication

Atorvastatin

Intervention Type: DRUG

Once daily application of lipid lowering medication

Placebo

Placebo Aspirin once daily and Placebo Atorvastatin once daily

Group Type: PLACEBO_COMPARATOR

Placebo Aspirin

Intervention Type: DRUG

Once daily application of placebo

Placebo Atorvastatin

Intervention Type: DRUG

Once daily application of placebo

Interventions

Aspirin

Once daily application of platelet inhibiting medication

Intervention Type: DRUG

Atorvastatin

Once daily application of lipid lowering medication

Intervention Type: DRUG

Placebo Aspirin

Once daily application of placebo

Intervention Type: DRUG

Placebo Atorvastatin

Once daily application of placebo

Intervention Type: DRUG

Other Intervention Names

Acetyl Salicyl Acid; Statin; Placebo Oral Tablet; Placebo Oral Tablet

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. med. Mahir Karakas

OTHER

Sponsor Role: lead

Responsible Party

Dr. med. Mahir Karakas

Coordinating Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mahir Karakas, MD

Role: STUDY_CHAIR

University Heart Center Hamburg

Locations

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

University of Leipzig

Leipzig, , Germany

Robert-Bosch-Hospital Stuttgart

Stuttgart, , Germany

University of Ulm

Ulm, , Germany

Countries

Germany

Other Identifiers

GRAY-ZONE

Identifier Type: -

Identifier Source: org_study_id