A placebo-controlled, randomized trial evaluating the efficacy and safety of acetylsalicylic acid and atorvastatin in patients at risk for cardiovascular disease

Phase 1

• Conditions: Myocardial Ischemia; MedDRA version: 20.0Level: LLTClassification code 10028601Term: Myocardial ischemiaSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2019-002833-12-DE
• Lead Sponsor: niversity Medical Centre Hamburg-Eppendorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-04
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

Key inclusion criteria:
• Patients presenting in the ER/ Chest Pain Unit (CPU), and expected
to be discharged within 24 hours
• Patients at risk for cardiovascular events as defined by at least one elevated high-sensitive troponin level during clinical work-up (> 90th percentile)
• Clinical exclusion of ACS, despite elevated hsTn (e.g. because of missing troponin dynamics)
• At least 50 years of age
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1800

Exclusion Criteria

Key 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 at the discretion of the treating physician (no routine measurement of LDL-cholesterol)
• Any known 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, known 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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified