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

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ClinicalTrials.gov Identifier: NCT03820466
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : April 30, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. med. Mahir Karakas, Universitätsklinikum Hamburg-Eppendorf

Tracking Information
First Submitted Date  ICMJE October 2, 2017
First Posted Date  ICMJE January 29, 2019
Last Update Posted Date April 30, 2021
Actual Study Start Date  ICMJE February 21, 2020
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 25, 2019)
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
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Platelet Inhibition and / or Lipid Lowering in Non-ACS-patients With Positive Troponin
Official Title  ICMJE 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
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
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Acute Chest Syndrome
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Aspirin
    Aspirin 100 mg once daily and Placebo Atorvastatin once daily
    Interventions:
    • Drug: Aspirin
    • Drug: Placebo Atorvastatin
  • Active Comparator: Atorvastatin
    Atorvastatin 20 mg once daily and Placebo Aspirin once daily
    Interventions:
    • Drug: Atorvastatin
    • Drug: Placebo Aspirin
  • Experimental: Aspirin-Atorvastatin
    Aspirin 100 mg once daily and Atorvastatin 20 mg once daily
    Interventions:
    • Drug: Aspirin
    • Drug: Atorvastatin
  • Placebo Comparator: Placebo
    Placebo Aspirin once daily and Placebo Atorvastatin once daily
    Interventions:
    • Drug: Placebo Aspirin
    • Drug: Placebo Atorvastatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 25, 2019)
3000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mahir Karakas, MD +4915222817493 m.karakas@uke.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03820466
Other Study ID Numbers  ICMJE GRAY-ZONE
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr. med. Mahir Karakas, Universitätsklinikum Hamburg-Eppendorf
Study Sponsor  ICMJE Dr. med. Mahir Karakas
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Mahir Karakas, MD University Heart Center Hamburg
PRS Account Universitätsklinikum Hamburg-Eppendorf
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP