Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Dabigatran Following Transient Ischemic Attack and Minor Stroke
Brief Summary: Rationale: To date, anticoagulant therapy in acute stroke has also been limited by excess hemorrhagic events. The oral anticoagulant dabigatran is a novel agent, which has been shown to be associated with much lower intracranial hemorrhage rates. It has been suggested that this agent may provide the superior benefits of anticoagulation in acute stroke, without the concomitant increase in hemorrhage risk associated with heparin/LMWH or warfarin.

Study Design: DATAS II is a randomized, open label blinded endpoint trial. Participants (n=300) with TIA or ischemic stroke (NIHSS score \<9) will be enrolled within 48 hours of symptom onset from approximately four (4) health care centres across Canada. All participants will have an MRI with DWI lesion volume \< 25 ml. Participants will be randomized 1:1 to treatment with dabigatran for 30 days or ASA 81 mg daily (current standard of care). All stroke patients will initially be screened with a non-contrast CT scan of the brain. The first MRI will be performed within 48 hours of symptom onset. Imaging studies will be repeated at day 30. All patients will be assessed clinically at Day 30 and Day 90.

Study Aims:

1. Establish the safety of early anticoagulation with the novel oral anticoagulant dabigatran in acute cerebrovascular syndrome patients.
2. Identify the rate of both symptomatic and asymptomatic hemorrhagic transformation (HT) associated with these treatments.
3. Identify predictors of HT associated with acute dabigatran treatment.

Hypothesis: The Investigators hypothesize that symptomatic HT rates in dabigatran and ASA treated patients will not be significantly different.

Study outcomes: The primary outcome is the rate of symptomatic hemorrhagic transformation (HT), defined as a parenchymal hematoma, which is \>30% of the infarcted area on DWI, with substantial space- occupying effect, associated with clinical worsening (≥4 point increase in National Institutes of Health Stroke Scale (NIHSS) score) within 5 weeks of treatment initiation. The major secondary outcome the rate of asymtomatic HT see on day 30 MRI sequence.


Options:
A: Arm Label: DU-176b 15 mg group; Type: EXPERIMENTAL; Interventions: Drug: Du-176b | Arm Label: Placebo group; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: Du-176b; Assigned to Arm(s): DU-176b 15 mg group | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Placebo group
B: Arm Label: Rivaroxaban; Type: EXPERIMENTAL; Interventions: Drug: Rivaroxaban, Drug: Matching placebo for Rivaroxaban arm (Warfarin placebo) | Arm Label: Warfarin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Warfarin, Drug: Matching placebo for Warfarin arm (Rivaroxaban placebo) | Intervention Type: DRUG; Name: Rivaroxaban; Assigned to Arm(s): Rivaroxaban | Intervention Type: DRUG; Name: Warfarin; Assigned to Arm(s): Warfarin | Intervention Type: DRUG; Name: Matching placebo for Rivaroxaban arm (Warfarin placebo); Assigned to Arm(s): Rivaroxaban | Intervention Type: DRUG; Name: Matching placebo for Warfarin arm (Rivaroxaban placebo); Assigned to Arm(s): Warfarin
C: Arm Label: Dabigatran therapy; Type: EXPERIMENTAL; Interventions: Drug: Dabigatran | Arm Label: Acetylsalicylic Acid thereapy; Type: ACTIVE_COMPARATOR; Interventions: Drug: Acetylsalicylic acid | Intervention Type: DRUG; Name: Dabigatran; Assigned to Arm(s): Dabigatran therapy | Intervention Type: DRUG; Name: Acetylsalicylic acid; Assigned to Arm(s): Acetylsalicylic Acid thereapy
D: Arm Label: Warfarin/placebo edoxaban; Type: ACTIVE_COMPARATOR; Interventions: Drug: warfarin tablets, Drug: placebo edoxaban | Arm Label: high dose edoxaban/placebo warfarin; Type: EXPERIMENTAL; Interventions: Drug: Edoxaban tablets (high dose regimen-60mg), Drug: placebo warfarin | Arm Label: low dose edoxaban/placebo warfarin; Type: EXPERIMENTAL; Interventions: Drug: Edoxaban tablets (low dose regimen-30mg), Drug: placebo warfarin | Intervention Type: DRUG; Name: warfarin tablets; Assigned to Arm(s): Warfarin/placebo edoxaban | Intervention Type: DRUG; Name: Edoxaban tablets (high dose regimen-60mg); Assigned to Arm(s): high dose edoxaban/placebo warfarin | Intervention Type: DRUG; Name: Edoxaban tablets (low dose regimen-30mg); Assigned to Arm(s): low dose edoxaban/placebo warfarin | Intervention Type: DRUG; Name: placebo warfarin; Assigned to Arm(s): high dose edoxaban/placebo warfarin, low dose edoxaban/placebo warfarin | Intervention Type: DRUG; Name: placebo edoxaban; Assigned to Arm(s): Warfarin/placebo edoxaban

Answer: C