A Phase 4 interventional study of Sertraline and No treatment in Depression and Coronary Artery Disease, sponsored by Assistance Publique - Hôpitaux de Paris. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-03.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 4, Interventional, and Treatment
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.
Rational:
40% of patients hospitalized for acute coronary syndrome (ACS) present depressive symptoms. The increase in cardiovascular morbidity and mortality at 6 months (hazard ratio = 3.5) could partly be explained by an alteration of the platelet parameters in patients with depression.
Sertraline is a potent inhibitor of the selective serotonin reuptake (SSRI). At the platelet level, it decreases the secretion induced by collagen and causes the inhibition of serotonin reuptake and platelet activation, wider than the simple anti-serotonergic effect. Its efficacy on depression of patients with ACS has been demonstrated (-20% of ischemic events at 24 weeks vs placebo), partly independent of the correction of depressive symptoms, and with a wide safety action. Antiplatelet, anti-inflammatory and endothelial function effects of sertraline are demonstrated in healthy volunteers, in stable patients and in patients with heart failure, but have never been explored in ACS .
Multicenter, randomized, double-blind, controlled trial comparing SSRI and placebo in depressive patients with ACS.
A control (non depressive) ACS group will also do the clinical and laboratory follow-up at the same time (without drug administration), to constitute a reference for platelet parameters and to allow a comparison with the depressive ACS group treated with placebo.
Randomization and initiation of the treatment at the end of the hospitalization for ACS (possibly after reperfusion and stabilization of cardiac medication)
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 2 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cardiovascular
Psychiatric
Clinical and Biological
Contraindications to sertraline (placebo / sertraline group)
Regulatory
ACS, depression
Drug: Sertraline
ACS, depression
Drug: Placebo
ACS, no depression, no treatment
Drug: No treatment
Sertraline one capsule (50mg per day), which can be increased up to 200mg per day (maximum dose) for 6 months.
Also known as: Placebo one capsule, which can be increased up to 4 capsules per day (maximum dose) for 6 months.
Time dependent pattern of changes in platelet reactivity under sertraline compared to placebo within a time Frame of 6 months of treatment
To evaluate the time variation of the level of platelet reactivity (ADP induced residual aggregation) under sertraline compared to placebo within a time Frame of 6 months of treatment. Time Frame: T0 = before starting treatment with sertraline T1 = at discharge from the hospital = J1 after introduction of treatment with sertraline T2 = 6 weeks of treatment with sertraline T3 = 24 weeks of treatment with sertraline = end of treatment with sertraline T4 = 4 weeks after the end of treatment with sertraline (biological and psychiatric rebound)
Time frame: 0 day, 1 day, 6 weeks, 24 weeks, 28 weeks
Time dependent pattern of changes in platelet activation
Maximal platelet aggregation (ADP, Arachidonic Acid, Collagen), markers of platelet activation (betaTG, CD40s)
Time frame: 0 day, 1 day, 6 weeks, 24 weeks, 28 weeks
Time dependent pattern of changes in inflammation markers
Dosage of inflammation markers (IL-6, CRP, Fg, myeloperoxydase)
Time frame: 0 day, 1 day, 6 weeks, 24 weeks, 28 weeks
Time dependent changes in Depression
Beck Depression Inventory (BDI)
Time frame: 0 day, 1 day, 6 weeks, 24 weeks, 28 weeks
Time dependent changes in Tobacco addiction
Fargenström test
Time frame: 0 day, 1 day, 6 weeks, 24 weeks, 28 weeks
Time dependent changes in Bleeding risk
Dosage of hemoglobin, hematocrit and follow-up of hemorrhage
Time frame: 0 day, 1 day, 6 weeks, 24 weeks, 28 weeks
This study is terminated, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris