Ignite Creation Date:
2024-05-06 @ 12:42 PM
Last Modification Date:
2024-10-26 @ 1:02 PM
Study NCT ID:
NCT03820466
Status:
TERMINATED
Last Update Posted:
2022-05-24
First Post:
2017-10-02
Brief Title:
Effect of Platelet Inhibition and or Lipid Lowering in Non-ACS-patients With Positive Troponin
Sponsor:
Dr med Mahir Karakas
Organization:
Universitätsklinikum Hamburg-Eppendorf
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
insufficient recruitment due to the pandemic situation
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GRAY-ZONE
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
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 3000 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None