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

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 - Acetylsalicylic acid and statin in subclinical myocardial ischemia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002833-12-DE

Enrollment

3000

Registered

2019-10-04

Start date

2020-01-27

Completion date

Unknown

Last updated

2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Ischemia MedDRA version: 20.0 Level: LLT Classification code 10028601 Term: Myocardial ischemia System Organ Class: 100000004849

Interventions

Trade Name: ASS-ratiopharm 100 mg Pharmaceutical Form: Coated tablet INN or Proposed INN: ACETYLSALICYLIC ACID Current Sponsor code: ASS Concentration unit: mg milligram(s) Concentration type: equal C

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate if platelet inhibition with Aspirin 100 mg (Acetylsalicylic acid / ASA) and/or lowering of LDL-cholesterol with Atorvastatin 20 mg (Statin) is superior to placebo in reduction of death, myocardial infarction (MI) and coronary revascularization in patients with symptoms suggestive for Acute Coronary Syndrome (ACS) and elevated high-sensitivity troponin (hsTn) values, not classified as having ACS;Secondary Objective: The secondary efficacy objectives are to compare the active treatment and placebo groups with respect to: 1.) The risk of the composite endpoint of first occurrence of death and MI 2.) The risk of the composite endpoint of first occurrence of death, MI, stroke, TIA, coronary revascularization or rehospitalization for unstable angina pectoris 3.) The risk of the composite endpoint of first occurrence of death, MI, or stroke 4.) Mortality 5) Bleeding events 6.) Change (fold induction) in cardio-renal biomarkers from baseline to end of study visit (biomarkers will be measured in PIs core lab at end of study) 7.) Cancer 8.) Disability-free survival;Primary end point(s): Primary efficacy endpoint: Time to MI, coronary revascularization, or death, whatever comes first;Timepoint(s) of evaluation of this end point: during at least 12 months follow-up	—

Measure

Time frame

Main Objective: To evaluate if platelet inhibition with Aspirin 100 mg (Acetylsalicylic acid / ASA) and/or lowering of LDL-cholesterol with Atorvastatin 20 mg (Statin) is superior to placebo in reduction of death, myocardial infarction (MI) and coronary revascularization in patients with symptoms suggestive for Acute Coronary Syndrome (ACS) and elevated high-sensitivity troponin (hsTn) values, not classified as having ACS;Secondary Objective: The secondary efficacy objectives are to compare the active treatment and placebo groups with respect to: 1.) The risk of the composite endpoint of first occurrence of death and MI 2.) The risk of the composite endpoint of first occurrence of death, MI, stroke, TIA, coronary revascularization or rehospitalization for unstable angina pectoris 3.) The risk of the composite endpoint of first occurrence of death, MI, or stroke 4.) Mortality 5) Bleeding events 6.) Change (fold induction) in cardio-renal biomarkers from baseline to end of study visit (biomarkers will be measured in PIs core lab at end of study) 7.) Cancer 8.) Disability-free survival;Primary end point(s): Primary efficacy endpoint: Time to MI, coronary revascularization, or death, whatever comes first;Timepoint(s) of evaluation of this end point: during at least 12 months follow-up

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Secondary

Measure	Time frame
Secondary end point(s): Key secondary endpoints: The secondary efficacy objectives are to compare the active treatment and placebo groups with respect to: 1.) The risk of the composite endpoint of first occurrence of death and MI 2.) The risk of the composite endpoint of first occurrence of death, MI, stroke, TIA, coronary revascularization or rehospitalization for unstable angina pectoris 3.) The risk of the composite endpoint of first occurrence of death, MI, or stroke 4.) Mortality 5) Bleeding events 6.) Change (fold induction) in cardio-renal biomarkers from baseline to end of study visit (biomarkers will be measured in PIs core lab at end of study) 7.) Cancer 8.) Disability-free survival;Timepoint(s) of evaluation of this end point: during at least 12 months follow-up	—

Measure

Time frame

Secondary end point(s): Key secondary endpoints: The secondary efficacy objectives are to compare the active treatment and placebo groups with respect to: 1.) The risk of the composite endpoint of first occurrence of death and MI 2.) The risk of the composite endpoint of first occurrence of death, MI, stroke, TIA, coronary revascularization or rehospitalization for unstable angina pectoris 3.) The risk of the composite endpoint of first occurrence of death, MI, or stroke 4.) Mortality 5) Bleeding events 6.) Change (fold induction) in cardio-renal biomarkers from baseline to end of study visit (biomarkers will be measured in PIs core lab at end of study) 7.) Cancer 8.) Disability-free survival;Timepoint(s) of evaluation of this end point: during at least 12 months follow-up

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Countries

Germany

Contacts

Public ContactMahir Karakas

University Medical Centre Hamburg-Eppendorf

m.karakas@uke.de004940741057975

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026