Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-24 @ 4:25 PM
Study NCT ID:
NCT03820466
Status:
TERMINATED
Last Update Posted:
2022-05-24
First Post:
2017-10-02
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Platelet Inhibition and / or Lipid Lowering in Non-ACS-patients With Positive Troponin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056586', 'term': 'Acute Chest Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D000755', 'term': 'Anemia, Sickle Cell'}, {'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D000069059', 'term': 'Atorvastatin'}, {'id': 'D019161', 'term': 'Hydroxymethylglutaryl-CoA Reductase Inhibitors'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D000924', 'term': 'Anticholesteremic Agents'}, {'id': 'D000960', 'term': 'Hypolipidemic Agents'}, {'id': 'D000963', 'term': 'Antimetabolites'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D057847', 'term': 'Lipid Regulating Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'whyStopped': 'insufficient recruitment due to the pandemic situation', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-17', 'studyFirstSubmitDate': '2017-10-02', 'studyFirstSubmitQcDate': '2019-01-25', 'lastUpdatePostDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Myocardial infarction and/ or cardiovascular death and/ or revascularization', 'timeFrame': 'Until last patient has completed 12 months of follow-up', 'description': 'Time to myocardial infarction, coronary revascularization, or death, whatever comes first'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aspirin', 'Atorvastatin', 'Troponin'], 'conditions': ['Acute Chest Syndrome']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with symptoms suggestive for ACS presenting within 48 hours after onset in the ER/ Chest Pain Unit (CPU)\n* Patient has at least one elevated high-sensitivity troponin I or T value\n* Chest pain is classified as non-ACS, despite elevated hsTn (e.g. because of missing troponin dynamics)\n* At least 50 years of age\n\nExclusion Criteria:\n\n* Indication for antiplatelet therapy (e.g transient ischemic attack, or stable coronary artery diseases -CAD) or anticoagulation therapy (such as atrial fibrillation)\n* Indication for anti-lipid therapy\n* 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)\n* Untreated clinically significant CAD requiring revascularization\n* Hemoglobin value below 8 mg/d, and/or creatinine kinase ≥3 times ULN, and/or AST or ALT ≥3 times ULN\n* Active malignancy of any organ system, treated or untreated. Subjects have to be in remission for at least 36 months to be eligible.'}, 'identificationModule': {'nctId': 'NCT03820466', 'acronym': 'GRAY-ZONE', 'briefTitle': 'Effect of Platelet Inhibition and / or Lipid Lowering in Non-ACS-patients With Positive Troponin', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'GRAY-ZONE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Aspirin', 'description': 'Aspirin 100 mg once daily and Placebo Atorvastatin once daily', 'interventionNames': ['Drug: Aspirin', 'Drug: Placebo Atorvastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Atorvastatin', 'description': 'Atorvastatin 20 mg once daily and Placebo Aspirin once daily', 'interventionNames': ['Drug: Atorvastatin', 'Drug: Placebo Aspirin']}, {'type': 'EXPERIMENTAL', 'label': 'Aspirin-Atorvastatin', 'description': 'Aspirin 100 mg once daily and Atorvastatin 20 mg once daily', 'interventionNames': ['Drug: Aspirin', 'Drug: Atorvastatin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo Aspirin once daily and Placebo Atorvastatin once daily', 'interventionNames': ['Drug: Placebo Aspirin', 'Drug: Placebo Atorvastatin']}], 'interventions': [{'name': 'Aspirin', 'type': 'DRUG', 'otherNames': ['Acetyl Salicyl Acid'], 'description': 'Once daily application of platelet inhibiting medication', 'armGroupLabels': ['Aspirin', 'Aspirin-Atorvastatin']}, {'name': 'Atorvastatin', 'type': 'DRUG', 'otherNames': ['Statin'], 'description': 'Once daily application of lipid lowering medication', 'armGroupLabels': ['Aspirin-Atorvastatin', 'Atorvastatin']}, {'name': 'Placebo Aspirin', 'type': 'DRUG', 'otherNames': ['Placebo Oral Tablet'], 'description': 'Once daily application of placebo', 'armGroupLabels': ['Atorvastatin', 'Placebo']}, {'name': 'Placebo Atorvastatin', 'type': 'DRUG', 'otherNames': ['Placebo Oral Tablet'], 'description': 'Once daily application of placebo', 'armGroupLabels': ['Aspirin', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12203', 'city': 'Berlin', 'country': 'Germany', 'facility': 'University of Berlin, Campus Benjamin-Franklin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '38642', 'city': 'Goslar', 'country': 'Germany', 'facility': 'Asklepios Harz-Hospital Goslar', 'geoPoint': {'lat': 51.90425, 'lon': 10.42766}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'University Heart Center Hamburg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'University of Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '04103', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'University of Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '70376', 'city': 'Stuttgart', 'country': 'Germany', 'facility': 'Robert-Bosch-Hospital Stuttgart', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': '89081', 'city': 'Ulm', 'country': 'Germany', 'facility': 'University of Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}], 'overallOfficials': [{'name': 'Mahir Karakas, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Heart Center Hamburg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. med. Mahir Karakas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Coordinating Principal Investigator', 'investigatorFullName': 'Dr. med. Mahir Karakas', 'investigatorAffiliation': 'Universitätsklinikum Hamburg-Eppendorf'}}}}