Effect of Platelet Inhibition and / or Lipid Lowering in Non-ACS-patients With Positive Troponin

Acute Chest Syndrome Clinical Trial

— GRAY-ZONE  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03820466
• Other study ID #: GRAY-ZONE
• Status: Terminated
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Acute Chest Syndrome

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