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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02463110
Recruitment Status : Terminated (Investigator's decision)
First Posted : June 4, 2015
Last Update Posted : May 3, 2016
Sponsor:
Collaborator:
Action Research Group
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE May 19, 2015
First Posted Date  ICMJE June 4, 2015
Last Update Posted Date May 3, 2016
Study Start Date  ICMJE July 2015
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2015)
Time dependent pattern of changes in platelet reactivity under sertraline compared to placebo within a time Frame of 6 months of treatment [ Time Frame: 0 day, 1 day, 6 weeks, 24 weeks, 28 weeks ]
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02463110 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2015)
  • Time dependent pattern of changes in platelet activation [ Time Frame: 0 day, 1 day, 6 weeks, 24 weeks, 28 weeks ]
    Maximal platelet aggregation (ADP, Arachidonic Acid, Collagen), markers of platelet activation (betaTG, CD40s)
  • Time dependent pattern of changes in inflammation markers [ Time Frame: 0 day, 1 day, 6 weeks, 24 weeks, 28 weeks ]
    Dosage of inflammation markers (IL-6, CRP, Fg, myeloperoxydase)
  • Time dependent changes in Depression [ Time Frame: 0 day, 1 day, 6 weeks, 24 weeks, 28 weeks ]
    Beck Depression Inventory (BDI)
  • Time dependent changes in Tobacco addiction [ Time Frame: 0 day, 1 day, 6 weeks, 24 weeks, 28 weeks ]
    Fargenström test
  • Time dependent changes in Bleeding risk [ Time Frame: 0 day, 1 day, 6 weeks, 24 weeks, 28 weeks ]
    Dosage of hemoglobin, hematocrit and follow-up of hemorrhage
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acute Myocardial Necrosis and Depression: Antiplatelet Effect of Reuptake Inhibition of Serotonin
Official Title  ICMJE Acute Myocardial Necrosis and Depression: Antiplatelet Effect of Reuptake Inhibition of Serotonin: The ANDROS Study
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.

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 = 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)

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Coronary Artery Disease
Intervention  ICMJE
  • Drug: Sertraline
    Sertraline one capsule (50mg per day), which can be increased up to 200mg per day (maximum dose) for 6 months.
  • Drug: No treatment
  • Drug: Placebo
    Other Name: Placebo one capsule, which can be increased up to 4 capsules per day (maximum dose) for 6 months.
Study Arms  ICMJE
  • Experimental: 1: Sertraline
    ACS, depression
    Intervention: Drug: Sertraline
  • Placebo Comparator: 2: Placebo
    ACS, depression
    Intervention: Drug: Placebo
  • 3: Control
    ACS, no depression, no treatment
    Intervention: Drug: No treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 2, 2016)
2
Original Estimated Enrollment  ICMJE
 (submitted: June 1, 2015)
225
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02463110
Other Study ID Numbers  ICMJE P110155
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Action Research Group
Investigators  ICMJE
Principal Investigator: Johanne SILVAIN, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP