Ignite Creation Date:
2024-05-06 @ 7:04 AM
Last Modification Date:
2024-10-26 @ 11:44 AM
Study NCT ID:
NCT02463110
Status:
TERMINATED
Last Update Posted:
2016-05-03
First Post:
2015-05-19
Brief Title:
Acute Myocardial Necrosis and Depression Antiplatelet Effect of Reuptake Inhibition of Serotonin
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Acute Myocardial Necrosis and Depression Antiplatelet Effect of Reuptake Inhibition of Serotonin The ANDROS Study
Status:
TERMINATED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Investigators decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ANDROS
Brief 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
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
Detailed Description:
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 35 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
40 of patients hospitalized for acute coronary syndrome ACS present depressive symptoms The increase in cardiovascular morbidity and mortality at 6 months hazard ratio 35 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None