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Clopidogrel and aspirin versus aspirin alone for the prevention of stroke in patients with a history of atrial fibrillation: subgroup analysis of the CHARISMA randomized trial.
Cerebrovasc Dis 2008; 25(4):344-7CD

Abstract

BACKGROUND

Aspirin offers modest reduction in stroke in patients with atrial fibrillation. Whether combination of aspirin with clopidogrel offers additional protection is unclear.

METHODS

Post-hoc subgroup analysis of 593 participants with a history of atrial fibrillation in the Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance (CHARISMA) randomized trial testing clopidogrel 75 mg per day plus aspirin (75-162 mg per day) vs. aspirin alone in patients with stable cardiovascular disease or multiple cardiovascular risk factors.

RESULTS

Mean patient age was 70 years, 78% were men, and hypertension, heart failure and diabetes were present in 78, 20 and 44%, respectively. During a median follow-up of 2.3 years, stroke (ischemic and hemorrhagic) occurred in 15 of 298 assigned to clopidogrel plus aspirin and in 14 of 285 given aspirin alone (hazard ratio, HR, 1.03, 95% CI 0.49-2.1). There was no difference in all-cause mortality (HR 1.1, 95% CI 0.6-1.9) or in the composite of stroke, myocardial infarction, or vascular death (HR = 1.2, 95% CI 0.7-2.0). Severe/fatal extracranial hemorrhage occurred in 6 patients with combination vs. 3 with aspirin alone.

CONCLUSIONS

This post-hoc subgroup analysis does not support the use of this combination over aspirin alone in patients with a history of atrial fibrillation pending results of ongoing larger randomized trials.

Authors+Show Affiliations

Department of Neurology, University of Texas Health Science Center, San Antonio, TX 78229-3900, USA. hartr@uthscsa.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

18303254

Citation

Hart, Robert G., et al. "Clopidogrel and Aspirin Versus Aspirin Alone for the Prevention of Stroke in Patients With a History of Atrial Fibrillation: Subgroup Analysis of the CHARISMA Randomized Trial." Cerebrovascular Diseases (Basel, Switzerland), vol. 25, no. 4, 2008, pp. 344-7.
Hart RG, Bhatt DL, Hacke W, et al. Clopidogrel and aspirin versus aspirin alone for the prevention of stroke in patients with a history of atrial fibrillation: subgroup analysis of the CHARISMA randomized trial. Cerebrovasc Dis. 2008;25(4):344-7.
Hart, R. G., Bhatt, D. L., Hacke, W., Fox, K. A., Hankey, G. J., Berger, P. B., ... Topol, E. J. (2008). Clopidogrel and aspirin versus aspirin alone for the prevention of stroke in patients with a history of atrial fibrillation: subgroup analysis of the CHARISMA randomized trial. Cerebrovascular Diseases (Basel, Switzerland), 25(4), pp. 344-7. doi:10.1159/000118380.
Hart RG, et al. Clopidogrel and Aspirin Versus Aspirin Alone for the Prevention of Stroke in Patients With a History of Atrial Fibrillation: Subgroup Analysis of the CHARISMA Randomized Trial. Cerebrovasc Dis. 2008;25(4):344-7. PubMed PMID: 18303254.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clopidogrel and aspirin versus aspirin alone for the prevention of stroke in patients with a history of atrial fibrillation: subgroup analysis of the CHARISMA randomized trial. AU - Hart,Robert G, AU - Bhatt,Deepak L, AU - Hacke,Werner, AU - Fox,Keith A A, AU - Hankey,Graeme J, AU - Berger,Peter B, AU - Hu,Tingfei, AU - Topol,Eric J, AU - ,, Y1 - 2008/02/27/ PY - 2007/10/15/received PY - 2007/10/17/accepted PY - 2008/2/28/pubmed PY - 2008/7/4/medline PY - 2008/2/28/entrez SP - 344 EP - 7 JF - Cerebrovascular diseases (Basel, Switzerland) JO - Cerebrovasc. Dis. VL - 25 IS - 4 N2 - BACKGROUND: Aspirin offers modest reduction in stroke in patients with atrial fibrillation. Whether combination of aspirin with clopidogrel offers additional protection is unclear. METHODS: Post-hoc subgroup analysis of 593 participants with a history of atrial fibrillation in the Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance (CHARISMA) randomized trial testing clopidogrel 75 mg per day plus aspirin (75-162 mg per day) vs. aspirin alone in patients with stable cardiovascular disease or multiple cardiovascular risk factors. RESULTS: Mean patient age was 70 years, 78% were men, and hypertension, heart failure and diabetes were present in 78, 20 and 44%, respectively. During a median follow-up of 2.3 years, stroke (ischemic and hemorrhagic) occurred in 15 of 298 assigned to clopidogrel plus aspirin and in 14 of 285 given aspirin alone (hazard ratio, HR, 1.03, 95% CI 0.49-2.1). There was no difference in all-cause mortality (HR 1.1, 95% CI 0.6-1.9) or in the composite of stroke, myocardial infarction, or vascular death (HR = 1.2, 95% CI 0.7-2.0). Severe/fatal extracranial hemorrhage occurred in 6 patients with combination vs. 3 with aspirin alone. CONCLUSIONS: This post-hoc subgroup analysis does not support the use of this combination over aspirin alone in patients with a history of atrial fibrillation pending results of ongoing larger randomized trials. SN - 1421-9786 UR - https://www.unboundmedicine.com/medline/citation/18303254/Clopidogrel_and_aspirin_versus_aspirin_alone_for_the_prevention_of_stroke_in_patients_with_a_history_of_atrial_fibrillation:_subgroup_analysis_of_the_CHARISMA_randomized_trial_ L2 - https://www.karger.com?DOI=10.1159/000118380 DB - PRIME DP - Unbound Medicine ER -