Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: VITATOPS - A Study of VITAmins TO Prevent Stroke
Brief Summary: The VITATOPS study is a multi-center, randomized, double blind, placebo-controlled secondary stroke prevention trial to determine whether the addition of vitamin supplements (B12 500 ug, B6 25 mg, Folate 2 mg) to best medical/surgical management (including modification of risk factors) will reduce the combined incidence of recurrent vascular events (stroke, myocardial infarction) and vascular death in patients with recent stroke or transient ischemic attack (TIA). All patients presenting to one of the participating neurologists or general physicians within seven months of stroke (ischemic or hemorrhagic) or TIA (eye or brain) are eligible for this trial. Eligible patients will be randomized in a double-blind fashion to receive multi-vitamins or placebo, 1 tablet daily. The primary outcome event is the composite event "stroke, myocardial infarction, or death from any vascular cause", whichever occurs first. Our target is to recruit a total of 8,000 patients over the next two years with a median follow-up of 2.5 years. Recruitment to the trial began in November 1998 and is planned to continue until December 2005. We aim to complete final follow-up by the end of 2006. However, the Steering Committee will be flexible in dictating the need for ongoing recruitment and continuing follow-up, depending on the overall rate of the primary outcome event in the entire cohort at each interim analysis.


Options:
A: Arm Label: Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug); Type: ACTIVE_COMPARATOR; Interventions: Drug: Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug) or placebo | Arm Label: Placebo Tablet; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DRUG; Name: Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug) or placebo; Assigned to Arm(s): Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug) | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo Tablet
B: Arm Label: vitamin supplements; Type: EXPERIMENTAL; Interventions: Drug: Folic Acid, Drug: Vitamin B6, Drug: Vitamin B12 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: Folic Acid; Assigned to Arm(s): vitamin supplements | Intervention Type: DRUG; Name: Vitamin B6; Assigned to Arm(s): vitamin supplements | Intervention Type: DRUG; Name: Vitamin B12; Assigned to Arm(s): vitamin supplements | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Placebo
C: Intervention Type: BEHAVIORAL; Name: ascorbic acid, vitamin E, beta carotene, selenium, zinc; Assigned to Arm(s): N/A
D: Arm Label: Vitamin B12; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Vitamin B12 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin B12; Assigned to Arm(s): Vitamin B12 | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo; Assigned to Arm(s): Placebo

Answer: A