Effect of Platelet Inhibition and / or Lipid Lowering in Non-ACS-patients With Positive Troponin (GRAY-ZONE)
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ClinicalTrials.gov Identifier: NCT03820466 |
Recruitment Status :
Terminated
(insufficient recruitment due to the pandemic situation)
First Posted : January 29, 2019
Last Update Posted : May 24, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Chest Syndrome | Drug: Aspirin Drug: Atorvastatin Drug: Placebo Aspirin Drug: Placebo Atorvastatin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 68 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Care Provider, Outcomes Assessor) |
Primary Purpose: | Prevention |
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 |
Actual Study Start Date : | February 21, 2020 |
Actual Primary Completion Date : | December 2, 2021 |
Actual Study Completion Date : | April 7, 2022 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Aspirin
Aspirin 100 mg once daily and Placebo Atorvastatin once daily
|
Drug: Aspirin
Once daily application of platelet inhibiting medication
Other Name: Acetyl Salicyl Acid Drug: Placebo Atorvastatin Once daily application of placebo
Other Name: Placebo Oral Tablet |
Active Comparator: Atorvastatin
Atorvastatin 20 mg once daily and Placebo Aspirin once daily
|
Drug: Atorvastatin
Once daily application of lipid lowering medication
Other Name: Statin Drug: Placebo Aspirin Once daily application of placebo
Other Name: Placebo Oral Tablet |
Experimental: Aspirin-Atorvastatin
Aspirin 100 mg once daily and Atorvastatin 20 mg once daily
|
Drug: Aspirin
Once daily application of platelet inhibiting medication
Other Name: Acetyl Salicyl Acid Drug: Atorvastatin Once daily application of lipid lowering medication
Other Name: Statin |
Placebo Comparator: Placebo
Placebo Aspirin once daily and Placebo Atorvastatin once daily
|
Drug: Placebo Aspirin
Once daily application of placebo
Other Name: Placebo Oral Tablet Drug: Placebo Atorvastatin Once daily application of placebo
Other Name: Placebo Oral Tablet |
- Myocardial infarction and/ or cardiovascular death and/ or revascularization [ Time Frame: Until last patient has completed 12 months of follow-up ]Time to myocardial infarction, coronary revascularization, or death, whatever comes first

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820466
Germany | |
University of Berlin, Campus Benjamin-Franklin | |
Berlin, Germany, 12203 | |
Asklepios Harz-Hospital Goslar | |
Goslar, Germany, 38642 | |
University Heart Center Hamburg | |
Hamburg, Germany, 20246 | |
University of Heidelberg | |
Heidelberg, Germany, 69120 | |
University of Leipzig | |
Leipzig, Germany, 04103 | |
Robert-Bosch-Hospital Stuttgart | |
Stuttgart, Germany, 70376 | |
University of Ulm | |
Ulm, Germany, 89081 |
Study Chair: | Mahir Karakas, MD | University Heart Center Hamburg |
Responsible Party: | Dr. med. Mahir Karakas, Coordinating Principal Investigator, Universitätsklinikum Hamburg-Eppendorf |
ClinicalTrials.gov Identifier: | NCT03820466 |
Other Study ID Numbers: |
GRAY-ZONE |
First Posted: | January 29, 2019 Key Record Dates |
Last Update Posted: | May 24, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Aspirin Atorvastatin Troponin |
Acute Chest Syndrome Lung Diseases Respiratory Tract Diseases Respiration Disorders Anemia, Sickle Cell Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn Aspirin Atorvastatin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Anticholesteremic Agents Hypolipidemic Agents |