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Lip (phase 2 AZD0837) study, 2009	TRC11459
[NCT00684307] unpublished (or not yet fully published) trial Preliminary results	download pdf: AZD0837 | antithrombotics for atrial fibrillation

Treatments

Studied treatment	AZD0837 for 3-9 months
Control treatment	dose-adjusted Vitamin-K antagonists (VKA) (aiming for an international normalized ratio (INR) 2.0 to 3.0)
Remarks	4 doses: 150 mg od, 300mg od, 450 mg od and 200mg bid

Patients

Patients	patients with non-valvular atrial fibrillation (AF) with one or more additional risk factors for stroke
Inclusion criteria	1) Nonvalvular AF (NVAF) verified by at least two ECGs in the last year separated by at least one week.; 2) Previous cerebral ischemic attack (stroke or TIA, >30 days prior to randomization); 3) Previous systemic embolism.; 4) Symptomatic congestive heart failure (CHF); 5) Impaired left ventricular systolic function; 6) Diabetes mellitus; 7) Hypertension requiring anti-hypertensive treatment.;
Exclusion criteria	1) AF secondary to reversible disorders, eg hyperthyroidism, drugs and pulmonary embolism; 2) Known contraindication to VKA treatment; 3) Presence of a valvular heart disease, mechanical heart valves, active endocarditis, left ventricular aneurysm or thrombus, atrial myxoma or any condition other than AF requiring chronic anticoagulation treatment; 4) Conditions associated with increased risk of major bleeding for example: history of intracranial bleeding, history of bleeding gastrointestinal disorder or major surgical procedure or trauma two weeks prior to randomization;
Baseline characteristics	subgroup test b

Method and design

Randomized effectives	636 / 318 (studied vs. control)
Design	Parallel groups
Blinding	double blind
Follow-up duration	3 or 9 months
Primary endpoint	Safety variables
Studied endpoints	Safety variables, Pharmacokinetic parameters, Pharmacodynamic markers, Pharmacogenetics,

Remarks / Comments

phase 2

Results

No results available for this trial - unpublished or not fully published trial

Meta-analysis of all similar trials:

antithrombotics in atrial fibrillation for primary prevention of thromboembolic events

new oral anticoagulants in atrial fibrillation for all type of patients

Reference(s)

TrialResults-center ID	TRC11459
Trials register #	NCT00684307

unpublished (or not yet fully published) trial