NCT00501059: A Study to Assess the Efficacy and Safety of Enteric-Coated Acetylsalicylic…

Summary

The use of acetylsalicylic acid in the primary prevention of cardiovascular events has been extensively studied but to a lesser extent in patients with moderate levels of cardiovascular risk. The current study is designed to prove the efficacy and tolerability of 100 mg enteric-coated Aspirin versus placebo in the prevention of cardiovascular disease (CVD) events, which include fatal and nonfatal myocardial infarction, fatal and nonfatal stroke and CV death, in a population with no history of known CVD who are at moderate risk of major CHD events (approximately 10-20% 10 year CHD risk). This corresponds to a patient population mean 10-year CVD risk of approximately 30%. Subjects are treated in a standard care setting and may receive treatment for the underlying risk factors as defined by the treating physician. Outcome events will be adjudicated by an Endpoint Adjudication Committee and the study will be monitored by an independent Data Safety Monitoring Board.

Timeline

Start: 2007-07-05
Primary completion: 2016-11-15
Completion: 2016-11-15

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Acetylsalicylic Acid (Aspirin, BAYE4465) vs Placebo; p = 0.597; Log Rank NCT00501059 ↗

paper (hazard ratio [HR] 0·96; 95% CI 0·81-1·13; p=0·6038). PMID 30158069 ↗

Publications

Results Gaziano JM, Brotons C, Coppolecchia R, Cricelli C, Darius H, Gorelick PB, Howard G, Pearson TA, Rothwell PM, Ruilope LM, Tendera M, Tognoni G; ARRIVE Executive Committee. Use of aspirin to reduce risk of initial vascular events in patients at moderate risk of cardiovascular disease (ARRIVE): a randomised, double-blind, placebo-controlled trial. Lancet. 2018 Sep 22;392(10152):1036-1046. doi: 10.1016/S0140-6736(18)31924-X. Epub 2018 Aug 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aspirin	Small molecule	100 mg	Oral

Indications