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

Sponsor

Dr. med. Mahir Karakas (Other)

Overall Status

Terminated

CT.gov ID

NCT03820466

Collaborator

(none)

Enrollment

Locations

Arms

25.5

Actual Duration (Months)

9.7

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Acute Chest Syndrome	Drug: Aspirin Drug: Atorvastatin Drug: Placebo Aspirin Drug: Placebo Atorvastatin	Phase 3

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: 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).

Study Design

Study Type:

Interventional

Actual Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Outcomes Assessor)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Feb 21, 2020

Actual Primary Completion Date :

Dec 2, 2021

Actual Study Completion Date :

Apr 7, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Aspirin Aspirin 100 mg once daily and Placebo Atorvastatin once daily	Drug: Aspirin Once daily application of platelet inhibiting medication Other Names: Acetyl Salicyl Acid Drug: Placebo Atorvastatin Once daily application of placebo Other Names: Placebo Oral Tablet
Active Comparator: Atorvastatin Atorvastatin 20 mg once daily and Placebo Aspirin once daily	Drug: Atorvastatin Once daily application of lipid lowering medication Other Names: Statin Drug: Placebo Aspirin Once daily application of placebo Other Names: Placebo Oral Tablet
Experimental: Aspirin-Atorvastatin Aspirin 100 mg once daily and Atorvastatin 20 mg once daily	Drug: Aspirin Once daily application of platelet inhibiting medication Other Names: Acetyl Salicyl Acid Drug: Atorvastatin Once daily application of lipid lowering medication Other Names: Statin
Placebo Comparator: Placebo Placebo Aspirin once daily and Placebo Atorvastatin once daily	Drug: Placebo Aspirin Once daily application of placebo Other Names: Placebo Oral Tablet Drug: Placebo Atorvastatin Once daily application of placebo Other Names: Placebo Oral Tablet

Outcome Measures

Primary Outcome Measures

Myocardial infarction and/ or cardiovascular death and/ or revascularization [Until last patient has completed 12 months of follow-up]
Time to myocardial infarction, coronary revascularization, or death, whatever comes first

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	University of Berlin, Campus Benjamin-Franklin	Berlin	Germany	12203
2	Asklepios Harz-Hospital Goslar	Goslar	Germany	38642
3	University Heart Center Hamburg	Hamburg	Germany	20246
4	University of Heidelberg	Heidelberg	Germany	69120
5	University of Leipzig	Leipzig	Germany	04103
6	Robert-Bosch-Hospital Stuttgart	Stuttgart	Germany	70376
7	University of Ulm	Ulm	Germany	89081