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| Sponsor: | Hallym University Medical Center |
|---|---|
| Information provided by (Responsible Party): | Hallym University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00874601 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Ischemic Stroke |
Drug: Diovan® (valsartan) |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
| Estimated Enrollment: | 578 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | July 2012 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Drug: Diovan® (valsartan)
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. |
|
No Intervention: 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Byung-chul Lee, MD, PhD | +82-31-380-3841 | ssbrain@hallym.ac.kr |
| Contact: Kyung-ho Yu, MD, PhD | +82-31-380-3843 | ykh1030@hallym.ac.kr |
| Korea, Republic of | |
| Hallym University Sacred Heart Hospital | Recruiting |
| Anyang, Gyeonggi, Korea, Republic of, 430-070 | |
| Contact: Byung-chul Lee, MD, PhD +82-31-380-3741 ssbrain@hallym.ac.kr | |
| Sub-Investigator: Kyung-ho Yu, MD, PhD | |
| Principal Investigator: | Byung-chul Lee, MD, PhD | Hallym University Medical Center |
More Information
| Responsible Party: | Hallym University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00874601 History of Changes |
| Other Study ID Numbers: | VENTURE |
| Study First Received: | April 1, 2009 |
| Last Updated: | October 4, 2011 |
| Health Authority: | South Korea: Institutional Review Board |
|
acute ischemic stroke blood pressure valsartan death dependancy |
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Ischemia Stroke Cerebral Infarction Pathologic Processes Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
Brain Infarction Brain Ischemia Valsartan Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |