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

Dr. med. Mahir Karakas

Status and phase: Terminated; Phase 3

Conditions: Acute Chest Syndrome

Treatments: Drug: Placebo Atorvastatin; Drug: Atorvastatin; Drug: Aspirin; Drug: Placebo Aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT03820466

GRAY-ZONE

Details and patient eligibility

About

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

Full 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).

Enrollment: 68 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 4 patient groups, including a placebo group

Aspirin

Active Comparator group

Description:

Aspirin 100 mg once daily and Placebo Atorvastatin once daily

Treatment:

Drug: Aspirin

Drug: Placebo Atorvastatin

Atorvastatin

Active Comparator group

Description:

Atorvastatin 20 mg once daily and Placebo Aspirin once daily

Treatment:

Drug: Placebo Aspirin

Drug: Atorvastatin

Aspirin-Atorvastatin

Experimental group

Description:

Aspirin 100 mg once daily and Atorvastatin 20 mg once daily

Treatment:

Drug: Aspirin

Drug: Atorvastatin

Placebo

Placebo Comparator group

Description:

Placebo Aspirin once daily and Placebo Atorvastatin once daily

Treatment:

Drug: Placebo Aspirin

Drug: Placebo Atorvastatin