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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 : Recruiting
First Posted : January 29, 2019
Last Update Posted : April 30, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. med. Mahir Karakas, Universitätsklinikum Hamburg-Eppendorf

Study Description
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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

Condition or disease Intervention/treatment Phase
Acute Chest Syndrome Drug: Aspirin Drug: Atorvastatin Drug: Placebo Aspirin Drug: Placebo Atorvastatin Phase 3

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 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
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Mahir Karakas, MD +4915222817493 m.karakas@uke.de

Locations
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Germany
University of Berlin, Campus Benjamin-Franklin Recruiting
Berlin, Germany, 12203
Contact: Ulf Landmesser, MD         
Asklepios Harz-Hospital Goslar Not yet recruiting
Goslar, Germany, 38642
Contact: Thomas Wittlinger, MD         
University Heart Center Hamburg Recruiting
Hamburg, Germany, 20246
Contact: Mahir Karakas, MD, MBA    +4915222817493    m.karakas@uke.de   
University of Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Moritz Biener, MD         
University of Leipzig Recruiting
Leipzig, Germany, 04103
Contact: Rolf Wachter, MD         
Robert-Bosch-Hospital Stuttgart Recruiting
Stuttgart, Germany, 70376
Contact: Klaus Storm, MD         
University of Ulm Recruiting
Ulm, Germany, 89081
Contact: Mirjam Kessler, MD         
Sponsors and Collaborators
Dr. med. Mahir Karakas
Investigators
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Study Chair: Mahir Karakas, MD University Heart Center Hamburg
More Information
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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: April 30, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. med. Mahir Karakas, Universitätsklinikum Hamburg-Eppendorf:
Aspirin
Atorvastatin
Troponin
Additional relevant MeSH terms:
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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