Status:
COMPLETED
Azelnidipine Anti-Coronary Atherosclerotic Trial in Hypertensive Patients by Serial Volumetric IVUS Analysis(ALPS-J)
Lead Sponsor:
Juntendo University
Collaborating Sponsors:
Japan Heart Foundation
Conditions:
Hypertension
Coronary Atherosclerosis
Eligibility:
All Genders
20-79 years
Phase:
PHASE4
Brief Summary
In patients with hypertension who undergo elective PCI, the effects of long-term administration of Calblock (azelnidipine) on plaque volume will be determined quantitatively by 3D-IVUS and compared wi...
Detailed Description
Clinical studies have demonstrated that calcium antagonists can reduce cardiovascular events in patients with coronary artery disease. Recently, suppression of the development of coronary atherosclero...
Eligibility Criteria
Inclusion
- Age: Between 20 and 79 years (at the time of giving informed consent).
- Sex: Either sex.
- Admission status: Outpatients.
- Patients requiring treatment for hypertension according to the JSH 2004 hypertension therapy guidelines before beginning this study
- Patients who have not used any calcium antagonists for at least 4 weeks before the beginning of this study.
- Patients who are scheduled to undergo elective PCI.
Exclusion
- Patients with acute coronary syndrome (ACS).
- Patients who have experienced Q-wave myocardial infarction within 4 weeks before beginning this study.
- Patients with renal dysfunction (serum creatinine \>2.0 mg/dL).
- Patients in whom PCI is unsuccessful.
- Patients with cardiogenic shock.
- Patients with moderate or severe congestive heart failure.
- Patients with 50% or more stenosis of the main trunk of the left coronary artery.
- Patients with other problems whom the investigator considers unsuitable for this study.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
199 Patients enrolled
Trial Details
Trial ID
NCT00294567
Start Date
December 1 2005
End Date
January 1 2011
Last Update
May 14 2021
Active Locations (1)
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1
Department of Cardiology, Juntendo University School of Medicine
Tokyo, Japan