Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03820466
Recruitment Status : Not yet recruiting
First Posted : January 29, 2019
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Brief Summary:
The study evaluates the effect of platelet inhibition and / or lipid lowering in non-ACS-patients with acute chest pain, and high-sensitivity troponin values above NSTEMI defined cutoffs

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 acute chest pain, but an ACS was ruled out, will be assigned randomly to Aspirin and/ or Atorvastatin versus placebo (2x2 factorial design).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Platelet Inhibition and / or Lipid Lowering in Non-ACS-patients With Acute Chest Pain, and High-sensitivity Troponin Values Above NSTEMI Defined Cutoffs
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain

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 Name: Acetyl Salicyl Acid

Drug: Placebo Atorvastatin
Once daily application of placebo
Other Name: 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 Name: Statin

Drug: Placebo Aspirin
Once daily application of placebo
Other Name: 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 Name: Acetyl Salicyl Acid

Drug: Atorvastatin
Once daily application of lipid lowering medication
Other Name: Statin

Placebo Comparator: Placebo
Placebo Aspirin once daily and Placebo Atorvastatin once daily
Drug: Placebo Aspirin
Once daily application of placebo
Other Name: Placebo Oral Tablet

Drug: Placebo Atorvastatin
Once daily application of placebo
Other Name: Placebo Oral Tablet




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with acute chest pain (typical or non-typical) presenting within 48 hours after onset in the ER/ Chest Pain Unit (CPU)
  • Patient has at least one high-sensitivity troponin value above the 99th percentile.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820466


Contacts
Layout table for location contacts
Contact: Mahir Karakas, MD +4915222817493 m.karakas@uke.de

Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
Layout table for investigator information
Study Chair: Mahir Karakas, MD University Heart Center Hamburg

Layout table for additonal information
Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT03820466     History of Changes
Other Study ID Numbers: GRAY-ZONE
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Aspirin
Atorvastatin
Troponin

Additional relevant MeSH terms:
Layout table for MeSH terms
Platelet Aggregation Inhibitors
Acute Chest Syndrome
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Aspirin
Atorvastatin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Anticholesteremic Agents
Hypolipidemic Agents