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

NCT03820466 | Terminated Phase 3 DMC

• 1 other identifier: GRAY-ZONE
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 7

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

Conditions

Acute Chest Syndrome

Keywords

Aspirin; Atorvastatin; Troponin

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Aspirin

ACTIVE COMPARATOR

Aspirin 100 mg once daily and Placebo Atorvastatin once daily

Drug: Aspirin; Drug: Placebo Atorvastatin

Atorvastatin

ACTIVE COMPARATOR

Atorvastatin 20 mg once daily and Placebo Aspirin once daily

Drug: Atorvastatin; Drug: Placebo Aspirin

Aspirin-Atorvastatin

EXPERIMENTAL

Aspirin 100 mg once daily and Atorvastatin 20 mg once daily

Drug: Aspirin; Drug: Atorvastatin

Placebo

PLACEBO COMPARATOR

Placebo Aspirin once daily and Placebo Atorvastatin once daily

Drug: Placebo Aspirin; Drug: Placebo Atorvastatin

Interventions

Aspirin DRUG

Once daily application of platelet inhibiting medication

Also known as: Acetyl Salicyl Acid

Aspirin; Aspirin-Atorvastatin

Atorvastatin DRUG

Once daily application of lipid lowering medication

Also known as: Statin

Aspirin-Atorvastatin; Atorvastatin

Placebo Aspirin DRUG

Once daily application of placebo

Also known as: Placebo Oral Tablet

Atorvastatin; Placebo

Placebo Atorvastatin DRUG

Once daily application of placebo

Also known as: Placebo Oral Tablet

Aspirin; Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. med. Mahir Karakas: lead

Study Sites (7)

University of Berlin, Campus Benjamin-Franklin

Berlin, 12203, Germany

Location

Asklepios Harz-Hospital Goslar

Goslar, 38642, Germany

Location

University Heart Center Hamburg

Hamburg, 20246, Germany

Location

University of Heidelberg

Heidelberg, 69120, Germany

Location

University of Leipzig

Leipzig, 04103, Germany

Location

Robert-Bosch-Hospital Stuttgart

Stuttgart, 70376, Germany

Location

University of Ulm

Ulm, 89081, Germany

Location

MeSH Terms

Conditions

Acute Chest Syndrome

Interventions

Aspirin; Atorvastatin; Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Anemia, Sickle Cell; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Officials

• Mahir Karakas, MD

  University Heart Center Hamburg

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Coordinating Principal Investigator

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: January 29, 2019
• Study Start: February 21, 2020
• Primary Completion: December 2, 2021
• Study Completion: April 7, 2022
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (7)