ANDROS 2015.
| Study characteristics | ||
| Methods | RCT design: 3‐arm parallel‐group trial Total N randomised: 2 Length of follow‐up: 6 months Analysis: unclear from trial registry (no analysis was reported, information on dropouts unclear) |
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| Participants | Location: France Number of study centres and setting: unclear, affiliated with Hôpitaux de Paris CAD criteria: ACS with elevated cardiac enzymes (above the 99th percentile of the upper limit of normal of the laboratory) Depression criteria: depressive symptoms on the BDI short form Other entry criteria: age 18 years and older, without antidepressant therapy for 3 months (valid only for the sertraline and placebo groups), affiliated to a social security scheme (beneficiary or assignee), signed a free and informed consent Exclusion criteria: 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 3 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, prothrombin time > 1.5 seconds, platelet rate < 100,000/mm3, hypersensitivity to the active substance or to any of the excipients (anhydrous lactose, pregelatinised corn starch, sodium laurilsulfate, magnesium stearate), treatment with pimozide, genetic galactose intolerance, malabsorption of glucose and galactose, lactase deficiency, women without effective contraception or pregnant or lactating or desiring pregnancy or within 6 months after randomisation, participation in biomedical research on other drugs during the period of participation, unable to follow the treatment Treatment: unclear Control: unclear Comparability of groups: unclear |
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| Interventions | Intervention 1: sertraline 50 mg/d, which can be increased up to 200 mg/d (maximum dose) Intervention 2: placebo 1 capsule per day, which can be increased up to 4 capsules per day (maximum dose) Control: no depression, no treatment Duration of treatment: 6 months |
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| Outcomes | Review outcomes: depression symptoms (BDI short form), platelet biomarkers (β‐thromboglobulin) Other outcomes: maximal platelet aggregation (ADP, arachidonic acid, collagen), markers of platelet activation (CD40s), inflammatory markers (interleukin‐6, C‐reactive protein, Fg, myeloperoxydase), tobacco addiction (Fargenström test), bleeding risk (haemoglobin, haematocrit, and follow‐up of haemorrhage) |
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| Funding | Assistance Publique ‐ Hôpitaux de Paris | |
| Notes | Comment: this study was terminated early after recruitment of 2 participants. No data were reported. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: No details reported |
| Allocation concealment (selection bias) | Unclear risk | Comment: Double blind (Participant, Investigator), not further specified |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: No details reported |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: No details reported |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: No details reported |
| Selective reporting (reporting bias) | Unclear risk | Comment: No details reported; trial terminated early after recruitment of two participants |
| Other bias | High risk | Comment: The trial was terminated early by the Investigator after recruitment of two participants. The sample size target was 225 |