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Comparison of Triflusal with Aspirin in the Secondary Prevention of Atherothrombotic Events; Α Randomised Clinical Trial
- Source :
- Current vascular pharmacology. 17(6)
- Publication Year :
- 2018
-
Abstract
- Background: Triflusal has demonstrated an efficacy similar to aspirin in the prevention of vascular events in patients with acute myocardial infarction (ΜΙ) and ischaemic stroke but with less bleeding events. Objective: We performed a randomised, multicentre, phase 4 clinical trial to compare the clinical efficacy and safety of triflusal versus aspirin, administered for 12 months in patients eligible to receive a cyclooxygenase-1 (COX-1) inhibitor. Methods: Patients with stable coronary artery disease or with a history of non-cardioembolic ischaemic stroke were randomly assigned to receive either triflusal 300 mg twice or 600 mg once daily or aspirin 100 mg once daily for 12 months. The primary efficacy endpoint was the composite of: (a) ΜΙ, (b) stroke (ischaemic or haemorrhagic), or, (c) death from vascular causes for the entire follow-up period. The primary safety endpoints were the rate of bleeding events as defined by Bleeding Academic Research Consortium (BARC) criteria. Results: At 12-month follow-up, an equivalent result was revealed between the triflusal (n=559) and aspirin (n=560) in primary efficacy endpoint. Specifically, the combined efficacy outcome rate (i.e. MI, stroke or death from vascular causes) difference was equal to -1.3% (95% confidence interval -1.1 to 3.5) and lied within the a-priori defined equivalence interval (p Conclusion: The efficacy of triflusal in the secondary prevention of vascular events is similar to aspirin when administered for 12 months. Importantly, triflusal significantly reduced the incidence of ΜΙ and showed a better safety profile compared with aspirin. : (ASpirin versus Triflusal for Event Reduction In Atherothrombosis Secondary prevention, ASTERIAS trial; Clinical Trials.gov Identifier: NCT02616497).
- Subjects :
- Male
medicine.medical_specialty
Time Factors
Myocardial Infarction
Hemorrhage
Coronary Artery Disease
030204 cardiovascular system & hematology
Brain Ischemia
Coronary artery disease
03 medical and health sciences
0302 clinical medicine
Recurrence
Risk Factors
Internal medicine
Secondary Prevention
Medicine
Humans
Cyclooxygenase Inhibitors
030212 general & internal medicine
Myocardial infarction
Stroke
Aged
Pharmacology
Aspirin
Greece
business.industry
Incidence (epidemiology)
Middle Aged
medicine.disease
Confidence interval
Salicylates
Clinical trial
Treatment Outcome
Intracranial Embolism
Triflusal
Female
Cardiology and Cardiovascular Medicine
business
Platelet Aggregation Inhibitors
medicine.drug
Subjects
Details
- ISSN :
- 18756212
- Volume :
- 17
- Issue :
- 6
- Database :
- OpenAIRE
- Journal :
- Current vascular pharmacology
- Accession number :
- edsair.doi.dedup.....2da1a13f6469598f53f97632897fcfc8