Acute Myocardial Necrosis and Depression: Antiplatelet Effect of Reuptake Inhibition of Serotonin

• Status: Terminated
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary purpose:

To evaluate the evolution in time of the antiaggregant platelet effect of sertraline (SSRI) compared to placebo in depressive patients with ACS (Acute Coronary Syndrome) and treated as recommended by a double antiplatelet therapy, aspirin and clopidogrel.

Hypothesis:

The benefits of SSRIs observed in depressive patients with ACS are related to an antiplatelet effect.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: ACTION Group – www.action-cœur.org; Action Research Group
• Treatments: Serotonin; Sertraline

Criteria

Inclusion Criteria:

• Patient Aged 18 years and older

• Patient Depressive without antidepressant therapy for three months (valid only for the sertraline and placebo groups)

• Patient With ACS with elevated cardiac enzymes (above the 99th percentile of the upper limit of normal of the laboratory)

• Patient That assessed depressive symptoms : Test Beck (13 items)

• Patient Affiliated to a social security scheme (beneficiary or assignee)

• Patient Having signed a free and informed consent

Exclusion Criteria:

• Cardiovascular

• History of serious bleeding (recent hemoglobin fall 5g / dl ( <3 months ), intracranial hemorrhage or hemorrhagic tamponade)

• Uncontrolled hypertension (SBP > 180 mmHg or DBP > 100 mmHg)

• Stroke <3 months

• Treatment with ticagrelor or prasugrel for the duration of the study.

• Psychiatric

• Psychosis, bipolar illness

• Dementia (Mini- Mental State Examination score < 23)

• Uncontrolled epilepsy

• Severe depression (score > 15) with suicidal risk identified by a psychiatrist (urgent treatment for depression needed)

• Patient experienced depression and treated in the last three months or currently receiving treatment

• Treatment with selective and non-selective monoamine oxidase inhibitors of the group A within 14 days prior to the introduction of sertraline

• Clinical and Biological

• Prothrombin time > 1.5 second

• Platelet rate < 100 000 / mm3

• Hematocrit rate < 25%

• Serum creatinine > 4.0 mg / dl

• Severe hepatic impairment (Child Pugh stage C)

• Contraindications to sertraline (placebo / sertraline group)

• Hypersensitivity to the active substance or to any of the excipients (anhydrous lactose, pregelatinized corn starch, sodium laurilsulfate , magnesium stearate)

• Treatment with pimozide

• Genetic galactose intolerance, malabsorption of glucose and galactose, lactase deficiency

• Regulatory

• Women without effective contraception or pregnant or lactating or desiring pregnancy or within 6 months after randomization

• Participation in biomedical research on other drugs during the period of participation

• Patients unable to follow the treatment