- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00294567
Azelnidipine Anti-Coronary Atherosclerotic Trial in Hypertensive Patients by Serial Volumetric IVUS Analysis(ALPS-J)
May 12, 2021 updated by: Juntendo University
Azelnidipine and Amlodipine Anti-Coronary Atherosclerotic Trial in Hypertensive Patients Undergoing Coronary Intervention by Serial Volumetric Intravascular Ultrasound Analysis in Junten Medical University (ALPS-J)
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 with those of amlodipine besilate (Norvasc or Amlodin).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 atherosclerotic plaque by calcium antagonists has been reported as one of the mechanisms involved.
Thus, calcium antagonists have been promising strategy for preventing the progression of the coronary atherosclerosis.
Various calcium antagonists are clinically available at present and these drugs may differ from each other with respect to the anti-atherosclerotic effects.
Consequently, we plan to perform the ALPS-J study to compare the effects of two long-acting calcium antagonists, azelnidipine and amlodipine, on plaque quantitatively by IVUS.
In this study, azelnidipine (16 mg/day) or amlodipine besilate (5 mg/day) will be administered to patients with hypertension for 48 weeks after elective PCI.
The plaque volume will be measured in each patient by IVUS at the time of PCI and 48 weeks after PCI.
Percent change in plaque volume from the baseline value will be used as the primary endpoints for evaluation of efficacy.
We plan to enroll 100 patients in each group for a total of 200 patients.
Study Type
Interventional
Enrollment (Actual)
199
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Tokyo, Japan
- Department of Cardiology, Juntendo University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Amlodipine
|
Drug: amlodipine Drug: azelnidipine
|
Active Comparator: 2
Azelnidipine
|
Drug: amlodipine Drug: azelnidipine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percent change in plaque volume from the baseline value. (IVUS) Percent change in plaque volume = (plaque volume after 48 weeks of drug administration - baseline plaque volume) / baseline plaque volume
Time Frame: 48Weeks
|
48Weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change of plaque volume from the baseline value. (IVUS) Amount change and percent change in Minimal lumen diameter and % stenosis. (Quantitative Coronary Analysis) Change of intimal thickening volume in-stent.
Time Frame: 48Weeks
|
48Weeks
|
Correlativity of plaque volume and inflammatory laboratory parameters (hs-CRP, MCP-1, PTX-3) Correlativity of laboratory parameters and blood pressure. Correlativity of plaque volume and antioxidant laboratory parameters (LPO, 8-isoprostane)
Time Frame: 48Weeks
|
48Weeks
|
The following treatments and incidence of events, Changes from baseline of laboratory parameters (TC, LDL-C,TG, HDL-C, hs-CRP, MCP-1, LPO, 8-isoprostane, PTX-3) after 48 weeks of drug administration. Correlativity of plaque volume and blood pressure.
Time Frame: 48Weeks
|
48Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: HIROYUKI MD DAIDA, Director of Cardiology Professor of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Miyauchi K, Daida H. [Azelnidipine and amlodipine anti-coronary atherosclerosis trial in hypertensive patients undergoing coronary intervention by serial volumetric intravascular ultrasound analysis in Juntendo Medical University]. Nihon Naika Gakkai Zasshi. 2012 Oct 10;101(10):3002-11. doi: 10.2169/naika.101.3002. No abstract available. Japanese.
- Kojima T, Miyauchi K, Yokoyama T, Yokoyama K, Kurata T, Suwa S, Kawamura M, Tamura H, Okazaki S, Inoue K, Fujiwara Y, Sumiyoshi M, Tanimoto K, Nakazato Y, Yamagami S, Hiro T, Komiyama N, Daida H. Azelnidipine and amlodipine anti-coronary atherosclerosis trial in hypertensive patients undergoing coronary intervention by serial volumetric intravascular ultrasound analysis in Juntendo University (ALPS-J). Circ J. 2011;75(5):1071-9. doi: 10.1253/circj.cj-11-0141. Epub 2011 Apr 7.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2005
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
February 20, 2006
First Submitted That Met QC Criteria
February 21, 2006
First Posted (Estimate)
February 22, 2006
Study Record Updates
Last Update Posted (Actual)
May 14, 2021
Last Update Submitted That Met QC Criteria
May 12, 2021
Last Verified
October 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Coronary Artery Disease
- Myocardial Ischemia
- Hypertension
- Atherosclerosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Amlodipine
- Calcium
- Calcium Channel Blockers
Other Study ID Numbers
- JHF-17NOV2005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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