Evidence map›Paper›PMID 23890047›Full record

Trial reportTrials2013

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, Ma Cruz Gómez Fernández, Natalia Burgos-Alonso, Ernest Vinyoles, Ricardo San Vicente Blanco, Gonzalo Grandes, TAHPS group

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IVMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01741922 (Effectiveness of the Timing of the Administration of Aspirin in Hypertensive Patients Treated With Low Doses of Acetyl Salicylic Acid for Secondary Prevention - TAHPS), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact, top 83% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01741922 phase3completednot on this map

Effectiveness of the Timing of the Administration of Aspirin in Hypertensive Patients Treated With Low Doses of Acetyl Salicylic Acid for Secondary Prevention - TAHPS

TypeinterventionalSponsorBasque Health ServiceRan2012 to 2016Enrolled230ConditionsHypertensionArmsASA evening, Acetylsalicylic morning, Placebos morning, Placebo evening
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

Ma Victoria Ruíz-ArzalluzPrimary Care Research Unit-Bizkaia, Basque Health Service (Osakidetza), Bilbao, Spain. MARIAVICTORIALOURDES.RUIZARZALLUZ@osakidetza.net
Ma Cruz Gómez Fernández
Natalia Burgos-Alonso
Ernest Vinyoles
Ricardo San Vicente Blanco
Gonzalo Grandes
TAHPS group
Osakidetza · ESInstitut Universitari d'Investigació en Atenció Primària Jordi Gol · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 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/

designThis 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 registrationClinicalTrials.gov NCT01741922.

Indexed as

Circadian RhythmResearch DesignAntihypertensive AgentsAspirinBlood PressureBlood Pressure Monitoring, AmbulatoryClinical ProtocolsCross-Over StudiesDrug Administration ScheduleHumansHypertensionPlatelet Aggregation InhibitorsProspective StudiesSecondary PreventionSpainTime FactorsAntihypertensive AgentsAspirinPlatelet Aggregation Inhibitors

Identifiers

PMID23890047
PMCPMC3750457
OpenAlexW2112151899

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.