Azelnidipine Anti-Coronary Atherosclerotic Trial in Hypertensive Patients by Serial Volumetric IVUS Analysis.(ALPS-J) - Full Text View

Sponsors and Collaborators:	Juntendo University Hospital Japan Heart Foundation
Information provided by:	Juntendo University Hospital
ClinicalTrials.gov Identifier:	NCT00294567

Purpose

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).

Condition	Intervention	Phase
Hypertension Coronary Atherosclerosis	Drug: Calcium channel blockers (amlodipine, azelnidipine)	Phase IV

MedlinePlus related topics: Calcium High Blood Pressure

Drug Information available for: Amlodipine Amlodipine besylate Azelnidipine Calcium gluconate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	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)

Further study details as provided by Juntendo University Hospital:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	December 2004
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Amlodipine	Drug: Calcium channel blockers (amlodipine, azelnidipine) Drug: amlodipine Drug: azelnidipine
2: Active Comparator Azelnidipine	Drug: Calcium channel blockers (amlodipine, azelnidipine) Drug: amlodipine Drug: azelnidipine

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.

Eligibility

Ages Eligible for Study:	20 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00294567

Locations

Japan
Department of Cardiology, Juntendo University School of Medicine
Tokyo, Japan

Sponsors and Collaborators

Juntendo University Hospital

Japan Heart Foundation

Investigators

Study Chair:

HIROYUKI MD DAIDA

Director of Cardiology Professor of Medicine

More Information

No publications provided

Responsible Party:	No ( No )
Study ID Numbers:	JHF-17NOV2005
Study First Received:	February 20, 2006
Last Updated:	October 21, 2008
ClinicalTrials.gov Identifier:	NCT00294567
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Juntendo University Hospital:

Hypertension
PCI
Calcium Channel Blockers
IVUS
Plaque

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Atherosclerosis
Calcium, Dietary
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Ischemia
Arteriosclerosis
Coronary Artery Disease
Amlodipine
Hypertension

Additional relevant MeSH terms:

Membrane Transport Modulators
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Calcium Channel Blockers

Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2009