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

May 17, 2022 updated by: Dr. med. Mahir Karakas

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

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

Study Overview

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 Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Berlin, Germany, 12203
        • University of Berlin, Campus Benjamin-Franklin
      • Goslar, Germany, 38642
        • Asklepios Harz-Hospital Goslar
      • Hamburg, Germany, 20246
        • University Heart Center Hamburg
      • Heidelberg, Germany, 69120
        • University of Heidelberg
      • Leipzig, Germany, 04103
        • University Of Leipzig
      • Stuttgart, Germany, 70376
        • Robert-Bosch-Hospital Stuttgart
      • Ulm, Germany, 89081
        • University of Ulm

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myocardial infarction and/ or cardiovascular death and/ or revascularization
Time Frame: Until last patient has completed 12 months of follow-up
Time to myocardial infarction, coronary revascularization, or death, whatever comes first
Until last patient has completed 12 months of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Mahir Karakas, MD, University Heart Center Hamburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2020

Primary Completion (Actual)

December 2, 2021

Study Completion (Actual)

April 7, 2022

Study Registration Dates

First Submitted

October 2, 2017

First Submitted That Met QC Criteria

January 25, 2019

First Posted (Actual)

January 29, 2019

Study Record Updates

Last Update Posted (Actual)

May 24, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

May 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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