Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2013 Jul 27:14:236.
doi: 10.1186/1745-6215-14-236.

Protocol for assessing the hypotensive effect of evening administration of acetylsalicylic acid: study protocol for a randomized, cross-over controlled trial

Ma Victoria Ruíz-Arzalluz  1 , Ma Cruz Gómez Fernández, Natalia Burgos-Alonso, Ernest Vinyoles, Ricardo San Vicente Blanco, Gonzalo Grandes; TAHPS group
Collaborators, Affiliations
Clinical Trial

Protocol for assessing the hypotensive effect of evening administration of acetylsalicylic acid: study protocol for a randomized, cross-over controlled trial

Ma Victoria Ruíz-Arzalluz et al. Trials. .

Abstract

Background: The objective of this study is to evaluate the antihypertensive effect of bedtime administration of low doses of aspirin in patients with treated hypertension and high cardiovascular risk on low-dose aspirin for secondary prevention, in order to optimize their usual treatment and reduce their cardiovascular risk.

Methods/design: This is a prospective phase IV multicentre, randomised, triple-blind, placebo-controlled, cross-over clinical trial. We will include 258 individuals with hypertension treated with low-dose aspirin for secondary prevention. These patients will be randomly recruited, by approximately 40 primary care physicians collaborating in the study, mainly in the Guipúzcoa West, Bilbao and Barcelona areas. The 258 patients will be randomly allocated to treatments to create two comparable groups. In the first period, the intervention group will take aspirin at night and placebo in the morning, while the control group will take their aspirin in the morning and placebo in the evening for 2 months. After a washout period of 15 to 30 days, there will be a second 2-month period for which groups will swap treatments. Participants will undergo ambulatory blood pressure monitoring at baseline, at the end of first period and then again at the beginning and end of the second period. The main outcome measure is the change in mean blood pressure over 24 h, and as secondary outcomes we will also assess changes in systolic and diastolic blood pressure, during the day and night, and the relationship between them. Lastly, we will explore whether non-dipper patients convert into dippers with the intervention.

Discussion: The goal of this research is to provide the scientific basis for indicating a change in the time of aspirin administration from morning to evening, by primary health practitioners, to improve the patient control of blood pressure and more effectively reduce their cardiovascular risk, by combining this hypotensive effect with the well-known anti-platelet effect of low-dose aspirin.

Trial registration: ClinicalTrials.gov NCT01741922.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Flow of the study.
See this image and copyright information in PMC

References

    1. Hermida RC, Ayala DE, Calvo C, López JE. Aspirin administered at bedtime, but not on awakening, has an effect on ambulatory blood pressure in hypertensive patients. J Am Coll Cardiol. 2005;46:975–983. doi: 10.1016/j.jacc.2004.08.071. - DOI - PubMed
    1. Hermida RC, Ayala DE, Calvo C, López JE, Mojón A, Rodríguez M, Fernández JR. Differing administration time-dependent effects of aspirin on blood pressure in dipper and non-dipper hypertensives. Hypertension. 2005;46:1060–1068. doi: 10.1161/01.HYP.0000172623.36098.4e. - DOI - PubMed
    1. Hermida RC, Ayala DE, Mojón A, Fernández JR. Ambulatory blood pressure control with bedtime aspirin administration in subjects with prehypertension. Am J Hypertens. 2009;22:896–903. doi: 10.1038/ajh.2009.83. - DOI - PubMed
    1. Hermida RC, Ayala DE, Calvo C, López JE, Fernández JR, Mojón A, Dominguez MJ, Covelo M. Administration time-dependent effects of aspirin on blood pressure in untreated hypertensive patients. Hypertension. 2003;41:1259–1267. doi: 10.1161/01.HYP.0000072335.73748.0D. - DOI - PubMed
    1. Collaboration AT. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ. 2002;324:71–86. doi: 10.1136/bmj.324.7329.71. - DOI - PMC - PubMed

Publication types

MeSH terms

Associated data