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- Klinische proef NCT00874601
Valsartan Efficacy on Modest Blood Pressure Reduction in Acute Ischemic Stroke (VENTURE)
Prospective, Randomized, Open-label, Blinded Endpoints, Multi-center Study to Evaluate the Efficacy of Modest Blood Pressure Reduction With Diovan® (Valsartan) in Acute Ischemic Stroke
The manipulation of blood pressure in acute cerebral ischemia has been a matter of debate until now. The investigators are clearly in need of more detailed data on how antihypertensive treatment affects outcome in acute phase of stroke.
This study will assess the effects of modest blood pressure (BP) lowering manipulation in acute period of ischemic stroke on death or dependency at 90-day.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Verwacht)
Fase
- Fase 4
Contacten en locaties
Studie Locaties
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Gyeonggi
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Anyang, Gyeonggi, Korea, republiek van, 430-070
- Werving
- Hallym University Sacred Heart Hospital
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Onderonderzoeker:
- Kyung-ho Yu, MD, PhD
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Age over 18 years
- Patients admitted within 24 hours and can be enrolled within 48 hours after qualifying ischemic stroke onset
- Patients with systolic blood pressure above 150 mm Hg and no more than 185 mm Hg at least twice of 3 or more times at 5 minutes intervals after resting
- Baseline NIHSS score at least 2 points, not more than 21 points
- Full functional independence prior to the present stroke indicated by an estimated premorbid mRS score of 0 or 1
- Informed consent from the patients or authorized representatives must be obtained in writing enrollment into the study
Exclusion Criteria:
- Patients who received thrombolytic therapy (intravenous or intraarterial)
- Patients with acute Intracerebral hemorrhage diagnosed by neuroimaging
- Patients with moderate or severe cardiac failure (New York Heart Association class III and IV)
- Patients with medical condition which need urgent or special antihypertentive therapy, such as hypertensive encephalopathy, aortic dissection, acute renal failure, acute pulmonary edema, or acute myocardial infarction
- Comatose at screening
- Known or suspected cerebral aneurysm or arteriovenous malformation
- Any other clinical relevant serious disease, including uncontrolled Diabetes, severe liver disease, or severe renal disease at the time of randomization
- Life expectancy of less than 3 months due to comorbid conditions, such as malignancy
- Participation in another drug trials or planned use of vascular interventions within the previous 30 days
- Women who are pregnant, breast feeding, or of child bearing potentials
- Contraindication to ARBs, such as history of angioedema to ARBs, renovascular hypertension
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: valsartan group
The valsartan group will be initially given 80 mg of Diovan® (valsartan) per oral once daily in the morning on day 1, and flexibly will be adjusted to a dose of 80 -320 mg per day during next 6 days if more than 30% of SBPs measured at least 4 times in a day will not get the target level of SBPs.
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The valsartan will be initially given 80 mg of Diovan® (valsartan) per oral once daily in the morning on day 1, and flexibly will be adjusted to a dose of 80 -320 mg per day during next 6 days if more than 30% of SBPs measured at least 4 times in a day will not get the target level of SBPs. In those patients not achieving target level of blood pressure (more than 15% reduction of initial blood pressure or below 145 mmHg of systolic blood pressure), an additional antihypertensive drugs (diuretics, beta blockers) can be given despite of Valsartan 320 mg. If the BP is considered to be low enough, dose of valsartan can be decreased to 40 mg per day. If the administration of valsartan is judged to be inappropriate by duty doctor due to any reasons, it can be stopped and the reasons will be recorded. |
Geen tussenkomst: control group
Patients on control group will not receive any other antihypertensive medication for first 7 days after stroke onset.
However, rescue therapy with antihypertensive agents can be permitted for episodes with severely elevated blood pressures during acute periods.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Death or dependency measured as functional status with the use of mRDs
Tijdsspanne: 90 days after the onset
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90 days after the onset
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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NIHSS
Tijdsspanne: 7 days and 90 days after stroke onset
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7 days and 90 days after stroke onset
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Byung-chul Lee, MD, PhD, Hallym University Medical Center
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- Necrose
- Hart-en vaatziekten
- Vaatziekten
- Cerebrovasculaire aandoeningen
- Hersenziekten
- Ziekten van het centrale zenuwstelsel
- Ziekten van het zenuwstelsel
- Ischemie van de hersenen
- Infarct
- Herseninfarct
- Hartinfarct
- Ischemische beroerte
- Ischemie
- Herseninfarct
- Moleculaire mechanismen van farmacologische werking
- Antihypertensiva
- Angiotensine II type 1-receptorblokkers
- Angiotensine-receptorantagonisten
- Valsartan
Andere studie-ID-nummers
- VENTURE
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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