- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03820466
Effect of Platelet Inhibition and / or Lipid Lowering in Non-ACS-patients With Positive Troponin (GRAY-ZONE)
May 17, 2022 updated by: Dr. med. Mahir Karakas
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
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
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
68
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Berlin, Germany, 12203
- University of Berlin, Campus Benjamin-Franklin
-
Goslar, Germany, 38642
- Asklepios Harz-Hospital Goslar
-
Hamburg, Germany, 20246
- University Heart Center Hamburg
-
Heidelberg, Germany, 69120
- University of Heidelberg
-
Leipzig, Germany, 04103
- University Of Leipzig
-
Stuttgart, Germany, 70376
- Robert-Bosch-Hospital Stuttgart
-
Ulm, Germany, 89081
- University of Ulm
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Aspirin
Aspirin 100 mg once daily and Placebo Atorvastatin once daily
|
Once daily application of platelet inhibiting medication
Other Names:
Once daily application of placebo
Other Names:
|
Active Comparator: Atorvastatin
Atorvastatin 20 mg once daily and Placebo Aspirin once daily
|
Once daily application of lipid lowering medication
Other Names:
Once daily application of placebo
Other Names:
|
Experimental: Aspirin-Atorvastatin
Aspirin 100 mg once daily and Atorvastatin 20 mg once daily
|
Once daily application of platelet inhibiting medication
Other Names:
Once daily application of lipid lowering medication
Other Names:
|
Placebo Comparator: Placebo
Placebo Aspirin once daily and Placebo Atorvastatin once daily
|
Once daily application of placebo
Other Names:
Once daily application of placebo
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Until last patient has completed 12 months of follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Mahir Karakas, MD, University Heart Center Hamburg
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 21, 2020
Primary Completion (Actual)
December 2, 2021
Study Completion (Actual)
April 7, 2022
Study Registration Dates
First Submitted
October 2, 2017
First Submitted That Met QC Criteria
January 25, 2019
First Posted (Actual)
January 29, 2019
Study Record Updates
Last Update Posted (Actual)
May 24, 2022
Last Update Submitted That Met QC Criteria
May 17, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Respiration Disorders
- Lung Diseases
- Hematologic Diseases
- Genetic Diseases, Inborn
- Anemia
- Anemia, Hemolytic, Congenital
- Anemia, Hemolytic
- Hemoglobinopathies
- Anemia, Sickle Cell
- Acute Chest Syndrome
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Aspirin
- Atorvastatin
Other Study ID Numbers
- GRAY-ZONE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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