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

Hypertension Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00294567
• Other study ID #: JHF-17NOV2005
• Status: Completed
• Phase: Phase 4
• Start date: December 2005
• Est. completion date: January 2011

Study information

• Verified date: October 2008
• Source: Juntendo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 with those of amlodipine besilate (Norvasc or Amlodin).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: January 2011
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Atherosclerosis
• Hypertension
• Myocardial Ischemia

Intervention

Drug:
• Calcium channel blockers (amlodipine, azelnidipine)
Drug: amlodipine Drug: azelnidipine

Locations

Country	Name	City	State
Japan	Department of Cardiology, Juntendo University School of Medicine	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Juntendo University	Japan Heart Foundation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		48Weeks
Secondary	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.		48Weeks
Secondary	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)		48Weeks
Secondary	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.		48Weeks