Aspirin Twice a Day in Patients With Diabetes and Acute Coronary Syndrome — ANDAMAN  

Obesity Clinical Trial

Official title: Aspirin With a Novel Twice-a-day Administration in Diabetic Patients With Acute Coronary Syndrome to Minimize Recurrence of Acute Ischemic Events or New Urgent Revascularization

Status Active, not recruiting

Clinical Trial Summary

To compare treatment with Aspirin Protect® twice a day (100 mg in the morning and 100 mg in the evening) versus Aspirin Protect® 100 mg once per day on a composite end-point of ischemic events in diabetic patients, or in patients with a known risk factor for non-optimal aspirin response (obesity, abdominal obesity or coronary event occurring with long-term aspirin),with acute coronary syndrome. It is expected that aspirin taken twice a day will reduce the occurrence of new ischemic event after acute coronary syndrome in diabetic patients or in patients with a known risk factor.

Clinical Trial Description

Patients who show high persistent platelet reactivity under aspirin are increasingly becoming an issue of clinical concern. Several studies have suggested that giving aspirin more frequently is very effective for reducing aspirin high persistent platelet reactivity, especially in diabetic patientsor in patients with a known risk factor. The aim of the study is to evaluate low dose of aspirin twice a day (compared to once a day) for the reduction of ischemic events in diabetic patients or in patients with a known risk factor, with acute coronary syndrome.

Experimental Design:

A multicenter, randomised, parallel group comparing aspirin given twice a day compared to once per day in diabetic patients, or in patients with a known risk factor for non-optimal aspirin response (obesity, abdominal obesity or coronary event occurring with long-term aspirin),with acute coronary syndrome.

Primary objective:

To compare treatment with Aspirin Protect® twice a day (100 mg in the morning and 100 mg in the evening) versus Aspirin Protect® 100 mg once per day on a composite end-point of ischemic events in diabetic patients, or in patients with a known risk factor for non-optimal aspirin response (obesity, abdominal obesity or coronary event occurring with long-term aspirin),with acute coronary syndrome.

Secondary objectives:

• To compare treatment with Aspirin Protect® twice a day (100 mg in the morning and 100 mg in the evening) versus Aspirin Protect® 100 mg once per day on net clinical benefit combining the ischemic and bleeding events in diabetic patients, or in patients with a known risk factor for non-optimal aspirin response (obesity, abdominal obesity or coronary event occurring with long-term aspirin),with acute coronary syndrome.

• To compare treatment with Aspirin Protect® twice a day (100 mg in the morning and 100 mg in the evening) versus Aspirin Protect® 100 mg once per day on cardiac events in diabetic patients, or in patients with a known risk factor for non-optimal aspirin response (obesity, abdominal obesity or coronary event occurring with long-term aspirin),with acute coronary syndrome.

• To compare treatment with Aspirin Protect® twice a day (100 mg in the morning and 100 mg in the evening) versus Aspirin Protect® 100 mg once per day in each of individual component of the main criterion.

• To confirm the safety of the innovative strategy (aspirin twice a day) concerning major bleeding events.

Study enrollment:

Multicentric national study involving 42 centers in France The duration is expected to be 24 months of recruitment. Patients will be randomized during the index hospitalization for acute coronary syndrome and before discharge between a conventional strategy of enteric coated aspirin 100mg per day with the standard of care or a innovative strategy of enteric coated aspirin 100mg morning and evening. Patients will be followed at one month, six months, one year and 18 months

Statistical analysis:

The study will include 2574 patients. We hypothesized that at 18 months, there will be an event rate of 22% for "death, MI, stroke, urgent revascularization, or acute arterial thrombotic event in the group treated with aspirin and we expect a decrease of the primary event of 20% (relative variation) using aspirin twice a day corresponding to an event rate of 17.6%.

A sample size of 1287 patients /group will allow an 80% power to detect this difference using a log-rank test at a two-sided 5% significance level. The study will include 2574 diabetic patients, or patients with a known risk factor for non-optimal aspirin response.

The primary analysis is based on the Intention To Treat population and the primary endpoint. The primary analysis on the primary endpoint will be carried out using a log-rank test for survival analysis. The 95% confidence interval of the hazard ratio will be presented. In addition the survival status during 18 months follow-up will be described by showing Kaplan-Meier curves.

Primary outcome according to pre-specified subgroups:

• Age: patients < 75 years or patient ≥75 years

• Gender: male or female

• Insulin vs no insulin treatment

• Type of acute coronary syndrome : STEMI vs NSTEMI

• Type of ADP inhibitor cotreatment

• Treatment strategy medical vs invasive (angioplasty or CABG surgery)

• Peripheral artery disease Yes/No

• GRACE score > or ≤140

• Left ventricular ejection fraction > or ≤ 40%

• Prior stroke Yes/No

• previous treatment with aspirin Yes/No

• initial HbA1C level > or ≤8%

• duration of diabetes > or ≤10 years

• Weight <60; 60-90; >90kg

• PPI use Yes/No ;

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Myocardial Ischemia
• Obesity
• Syndrome

• NCT number: NCT02520921
• Study type: Interventional
• Source: Assistance Publique - Hôpitaux de Paris
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: June 13, 2016
• Completion date: June 2024