Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Impact of Anticoagulation Therapy on the Cognitive Decline and Dementia in Patients With Non-Valvular Atrial Fibrillation (CAF Trial)
Brief Summary: Patients will be screened at Intermountain Medical Center and at Intermountain-affiliated anticoagulation clinics in the Salt Lake City region. Patients with non-valvular atrial fibrillation will be considered for study. After written informed consent is obtained, subjects who meet eligibility criteria will be randomized 1:1 to 2 treatment arms: Group 1: Dabigatran etexilate (150 mg BID if CrCL \> 30 mL/min, or 75 mg BID if CrCL \> 15 to 30 mL/min or per USPI; and Group 2: Warfarin (Dose-adjusted (INR 2.0 - 3.0). Assessment of kidney function every 6 months will be done for Group 1. Standard warfarin follow-up and education, based upon system criteria, will be done for Group 2. All subjects will be followed for 24 months, and will be assessed at 1-week, then 3-, 6-, 12-, 18- and 24-months post-anticoagulation visits as well as other visits deem necessary for clinical care. All subjects will undergo protocol-specified laboratory tests and will complete 6 standard, validated questionnaires at each follow-up visit following the week 1 visit, except at the 3-month visit when only one questionnaire will be administered. To determine brain volume and characteristic changes representative of micro-bleeding, the first 10 subjects in each treatment group who are willing and able to undergo the procedure will participate in a MRI sub-study. The cranial MRI will be done at baseline and at 24-months post-anticoagulation on this sub-group.


Options:
A: Arm Label: Isosorbide Mononitrate XL (ISMN); Type: ACTIVE_COMPARATOR; Interventions: Drug: Isosorbide Mononitrate XL (ISMN) | Arm Label: Cilostazol; Type: ACTIVE_COMPARATOR; Interventions: Drug: Cilostazol | Arm Label: ISMN XL and Cilostazol; Type: ACTIVE_COMPARATOR; Interventions: Drug: ISMN XL and Cilostazol | Arm Label: Neither ISMN nor cilostazol; Type: PLACEBO_COMPARATOR; Interventions: Other: Neither ISMN nor cilostazol | Intervention Type: DRUG; Name: Isosorbide Mononitrate XL (ISMN); Assigned to Arm(s): Isosorbide Mononitrate XL (ISMN) | Intervention Type: DRUG; Name: Cilostazol; Assigned to Arm(s): Cilostazol | Intervention Type: DRUG; Name: ISMN XL and Cilostazol; Assigned to Arm(s): ISMN XL and Cilostazol | Intervention Type: OTHER; Name: Neither ISMN nor cilostazol; Assigned to Arm(s): Neither ISMN nor cilostazol
B: Arm Label: Aspirin; Type: N/A; Interventions: Drug: 100 mg enteric-coated aspirin | Arm Label: Placebo; Type: N/A; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: 100 mg enteric-coated aspirin; Assigned to Arm(s): Aspirin | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
C: Arm Label: Aggrenox, Clopidogrel placebo, Micardis; Type: PLACEBO_COMPARATOR; Interventions: Drug: Aggrenox, Drug: Clopidogrel placebo, Drug: Micardis | Arm Label: Aggrenox placebo, clopidogrel,, Micardis; Type: PLACEBO_COMPARATOR; Interventions: Drug: Micardis, Drug: Aggrenox placebo, Drug: Clopidogrel | Arm Label: Aggrenox, clop placebo, micardis placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Aggrenox, Drug: Clopidogrel placebo, Drug: Micardis placebo | Arm Label: Aggrenox plcebo, clop, micardis placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Aggrenox placebo, Drug: Clopidogrel, Drug: Micardis placebo | Intervention Type: DRUG; Name: Aggrenox; Assigned to Arm(s): Aggrenox, Clopidogrel placebo, Micardis | Intervention Type: DRUG; Name: Aggrenox; Assigned to Arm(s): Aggrenox, clop placebo, micardis placebo | Intervention Type: DRUG; Name: Clopidogrel placebo; Assigned to Arm(s): Aggrenox, Clopidogrel placebo, Micardis | Intervention Type: DRUG; Name: Clopidogrel placebo; Assigned to Arm(s): Aggrenox, clop placebo, micardis placebo | Intervention Type: DRUG; Name: Micardis; Assigned to Arm(s): Aggrenox, Clopidogrel placebo, Micardis | Intervention Type: DRUG; Name: Micardis; Assigned to Arm(s): Aggrenox placebo, clopidogrel,, Micardis | Intervention Type: DRUG; Name: Aggrenox placebo; Assigned to Arm(s): Aggrenox placebo, clopidogrel,, Micardis | Intervention Type: DRUG; Name: Aggrenox placebo; Assigned to Arm(s): Aggrenox plcebo, clop, micardis placebo | Intervention Type: DRUG; Name: Clopidogrel; Assigned to Arm(s): Aggrenox placebo, clopidogrel,, Micardis | Intervention Type: DRUG; Name: Clopidogrel; Assigned to Arm(s): Aggrenox plcebo, clop, micardis placebo | Intervention Type: DRUG; Name: Micardis placebo; Assigned to Arm(s): Aggrenox, clop placebo, micardis placebo | Intervention Type: DRUG; Name: Micardis placebo; Assigned to Arm(s): Aggrenox plcebo, clop, micardis placebo
D: Arm Label: Dabigatran Etexilate; Type: EXPERIMENTAL; Interventions: Drug: Dabigatran Etexilate | Arm Label: Warfarin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Warfarin | Intervention Type: DRUG; Name: Dabigatran Etexilate; Assigned to Arm(s): Dabigatran Etexilate | Intervention Type: DRUG; Name: Warfarin; Assigned to Arm(s): Warfarin

Answer: D