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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03820466
Other study ID # GRAY-ZONE
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date February 21, 2020
Est. completion date April 7, 2022

Study information

Verified date May 2022
Source Universitätsklinikum Hamburg-Eppendorf
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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).


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Aspirin
Once daily application of platelet inhibiting medication
Atorvastatin
Once daily application of lipid lowering medication
Placebo Aspirin
Once daily application of placebo
Placebo Atorvastatin
Once daily application of placebo

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Dr. med. Mahir Karakas

Country where clinical trial is conducted

Germany, 

Outcome

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
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