Acute Chest Syndrome Clinical Trial
— GRAY-ZONEOfficial 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
Verified date | May 2022 |
Source | Universitätsklinikum Hamburg-Eppendorf |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Terminated |
Enrollment | 68 |
Est. completion date | April 7, 2022 |
Est. primary completion date | December 2, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Germany | University of Berlin, Campus Benjamin-Franklin | Berlin | |
Germany | Asklepios Harz-Hospital Goslar | Goslar | |
Germany | University Heart Center Hamburg | Hamburg | |
Germany | University of Heidelberg | Heidelberg | |
Germany | University of Leipzig | Leipzig | |
Germany | Robert-Bosch-Hospital Stuttgart | Stuttgart | |
Germany | University of Ulm | Ulm |
Lead Sponsor | Collaborator |
---|---|
Dr. med. Mahir Karakas |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Myocardial infarction and/ or cardiovascular death and/ or revascularization | Time to myocardial infarction, coronary revascularization, or death, whatever comes first | Until last patient has completed 12 months of follow-up |
Status | Clinical Trial | Phase | |
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