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

NCT02463110 | Terminated Phase 4

• 1 other identifier: P110155
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Coronary Artery Disease

Keywords

Acute Coronary Syndrome; Depression; Coronary Artery Disease; Myocardial Infarction; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• 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)

  0 day, 1 day, 6 weeks, 24 weeks, 28 weeks

Secondary Outcomes (5)

• Time dependent pattern of changes in platelet activation

  0 day, 1 day, 6 weeks, 24 weeks, 28 weeks

• Time dependent pattern of changes in inflammation markers

  0 day, 1 day, 6 weeks, 24 weeks, 28 weeks

• Time dependent changes in Depression

  0 day, 1 day, 6 weeks, 24 weeks, 28 weeks

• Time dependent changes in Tobacco addiction

  0 day, 1 day, 6 weeks, 24 weeks, 28 weeks

• Time dependent changes in Bleeding risk

  0 day, 1 day, 6 weeks, 24 weeks, 28 weeks

Study Arms (3)

1: Sertraline

EXPERIMENTAL

ACS, depression

Drug: Sertraline

2: Placebo

PLACEBO COMPARATOR

ACS, depression

Drug: Placebo

3: Control

OTHER

ACS, no depression, no treatment

Drug: No treatment

Interventions

Sertraline DRUG

Sertraline one capsule (50mg per day), which can be increased up to 200mg per day (maximum dose) for 6 months.

1: Sertraline

No treatment DRUG

3: Control

Placebo DRUG

Also known as: Placebo one capsule, which can be increased up to 4 capsules per day (maximum dose) for 6 months.

2: Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Action Research Group: collaborator

Study Sites (1)

ACTION Group - Pitié-Salpêtrière University Hospital (APHP)

Paris, 75013, France

Location

MeSH Terms

Conditions

Depression; Coronary Artery Disease; Acute Coronary Syndrome; Myocardial Infarction

Interventions

Sertraline; WW Domain-Containing Oxidoreductase

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Short Chain Dehydrogenase-Reductases; NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases; Alcohol Oxidoreductases; Oxidoreductases; Enzymes; Enzymes and Coenzymes; Tumor Suppressor Proteins; Neoplasm Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Johanne SILVAIN, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2015
• First Posted: June 4, 2015
• Study Start: July 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: May 3, 2016

Record last verified: 2016-05

Locations

FR (1)