search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Effects of low-dose aspirin taken at bedtime on hypertension


- candidate number3042
- NTR NumberNTR1206
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-mrt-2008
- Secondary IDsMEC P06.063 Medical Ethics Committee Leiden University Medical Center
- Public TitleEffects of low-dose aspirin taken at bedtime on hypertension
- Scientific TitleEffects of low-dose aspirin taken at bedtime on pathophysiologic mechanisms underlying hypertension in subjects with grade 1 essential hypertension: the Aspirin In Reduction of Tension (ASPIRETENSION) study
- ACRONYMASPIRETENSION study
- hypothesisWe hypothesise that aspirin 100mg at bedtime decreases tension by nocturnally lessening increase of the renin-angiotensin-aldosterone system, enhancing NO bioavailability, lessening autonomous nervous system activity or inhibiting COX-1 dependent thromboxane A2 production. Our objectives are to examine effects of aspirin 100mg at bedtime on these mechanisms.
- Healt Condition(s) or Problem(s) studiedHypertension, Renin-angiotensin-aldosterone system (RAAS), Aspirin
- Inclusion criteria1. Essential hypertension, without treatment <160/100 mm Hg, with treatment <140/90 mm Hg. If treated, treatment should be stopped before entering into study.
2. Age 18-80 year
3. Capacity to give informed consent
- Exclusion criteria1. Moderate or severe hypertension (>160/100)
2. Secondary hypertension
3. Personal history of cardiovascular events
4. Diabetes mellitus
5. Rheumatoid arthritis
6. Vasoactive medication
7. Any contraindication to use of aspirin
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2007
- planned closingdate30-apr-2008
- Target number of participants15
- InterventionsAfter patientís written informed consent and screening, subjects will be randomised between 100 mg aspirin at awakening and at bedtime in two treatment periods of 2 weeks. They will also get a placebo for respectively evening and morning to achieve full blinding. Between treatment periods, there will be a washout period of 4 weeks.
- Primary outcomeRenin-angiontensin-aldosterone system represented by renin activity
- Secondary outcomeSecondary endpoints are other determinants of RAAS-activity, markers of autonomous nervous system activity, COX-inhibition, vascular wall inflammation, vascular adhesion molecules and coagulation. We also measure 24-h blood pressure as well as central arterial stiffness (by non-invasive pulse wave analysis) to determine whether blood pressure effects are more centrally or peripherally located.
- TimepointsBefore both 2-week periods there will be a short visit of half an hour to our centre and after both periods there will be an admission for 24 hours to the research centre of general internal medicine. With regular intervals blood will be sampled, 24 hours urine will be collected, tension will be measured and also some other non-invasive experiments will be done.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD. PhD. M.V. Huisman
- CONTACT for SCIENTIFIC QUERIESMD. PhD. M.V. Huisman
- Sponsor/Initiator Leiden University Medical Center (LUMC), Vascular Medicine Unit, Department of General Internal Medicine and Endocrinology
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC), Vascular Medicine Unit, Department of General Internal Medicine and Endocrinology
- PublicationsN/A
- Brief summaryAspirin is a potent vasoprotective drug, widely used in secondary prevention of cardiovascular events. Until recently, it was thought not have any influence on tension. However, in some recent studies, 100mg aspirin, administered at bedtime and not upon awakening, showed to decrease blood pressure significantly, although underlying mechanisms are unclear. Therefore, in this study we will examine through which mechanisms aspirin 100mg at bedtime could have supplementary benefit to patients with hypertension by reducing their tension. We hypothesise that aspirin 100mg at bedtime decreases tension by nocturnally lessening increase of the renin-angiotensin-aldosterone system, enhancing NO bioavailability, lessening autonomous nervous system activity and inhibiting COX-1 dependent thromboxane A2 production. Our objectives are to examine effects of aspirin 100mg at bedtime on these mechanisms. The trial will have a prospective, randomised, placebo controlled, double blind and crossover study design. We will use 15 subjects with grade 1 essential hypertension (140/90-159/99 mmHg). Patients with more severe hypertension will be excluded, as well as them with secondary hypertension, personal history of cardiovascular events, diabetes mellitus, rheumatoid arthritis, vasoactive medication or any contraindication to use of aspirin. After patientís written informed consent and screening, subjects will be randomised between aspirin at awakening and at bedtime in two treatment periods of 2 weeks. They will also get a placebo for respectively evening and morning to achieve full blinding. Between treatment periods, there will be a washout period of 4 weeks. Before both periods there will be a short visit of half an hour to our centre and after both periods there will be an admission for 24 hours to the research centre of general internal medicine. With regular intervals blood will be sampled, 24 hours urine will be collected, tension will be measured and also some other non-invasive experiments will be done.
- Main changes (audit trail)
- RECORD31-jan-2008 - 28-okt-2008


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl