Abstract | BACKGROUND: OBJECTIVE: METHODS: A multicenter, placebo-controlled, double-blind, randomized trial was conducted at 49 investigating centers in France. Atrial fibrillation patients with a previous thromboembolic event or older than 65 years and with either a history of hypertension, a recent episode of heart failure or decreased left ventricular function were included in the study. Patients were treated with fluindione plus placebo (i.e. anticoagulant alone) or fluindione plus aspirin (i.e. combination therapy), with an international normalized ratio target of between 2 and 2.6. The combined primary endpoint was stroke (ischemic or hemorrhagic), myocardial infarction, systemic arterial emboli or vascular death. The secondary endpoint was the incidence of hemorrhagic complications. RESULTS: The 157 participants (average age 74 years; 52% women; 42% with paroxysmal atrial fibrillation) were followed for an average of 0.84 years. Three nonfatal thromboembolic events were observed (1 in the anticoagulation group, 2 in the combination group) and 6 patients died (3 in the anticoagulation group, 3 in the combination group), none of them from a thromboembolic complication. However, 3 deaths were secondary to severe hemorrhagic complications (1 in the anticoagulation group, 2 in the combination group). Nonfatal hemorrhagic complications occurred more often in the combination group (n = 10, 13.1%) compared to the anticoagulation group (n = 1, 1.2%) (p = 0.003). CONCLUSION:
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Authors | P Lechat, H Lardoux, A Mallet, P Sanchez, G Derumeaux, T Lecompte, L Maillard, J L Mas, F Mentre, F Pousset, L Lacomblez, G Pisica, S Solbes-Latourette, P Raynaud, P Chaumet-Riffaud, FFAACS (Fluindione, Fibrillation Auriculaire, Aspirin et Contraste Spontané) Investigators |
Journal | Cerebrovascular diseases (Basel, Switzerland)
(Cerebrovasc Dis)
Vol. 12
Issue 3
Pg. 245-52
( 2001)
ISSN: 1015-9770 [Print] Switzerland |
PMID | 11641591
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright 2001 S. Karger AG, Basel |
Chemical References |
- Anticoagulants
- Drug Combinations
- Phenindione
- fluindione
- Aspirin
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Topics |
- Administration, Oral
- Aged
- Anticoagulants
(administration & dosage, adverse effects, therapeutic use)
- Aspirin
(administration & dosage, adverse effects, therapeutic use)
- Atrial Fibrillation
(drug therapy)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Drug Combinations
- Female
- Hemorrhage
(chemically induced)
- Humans
- Male
- Phenindione
(administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
- Risk Factors
- Thromboembolism
(prevention & control)
- Treatment Outcome
- Vascular Diseases
(mortality)
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