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

Phase 4

Completed

• Conditions: Hypertension; Coronary Atherosclerosis
• Interventions: Drug: Calcium channel blockers (amlodipine, azelnidipine)

• Registration Number: NCT00294567
• Lead Sponsor: Juntendo University

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 with those of amlodipine besilate (Norvasc or Amlodin).

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 Timeline

• Study Start: 2005-12
• Study First Submitted: 2006-02-20
• Study First Submitted QC: 2006-02-21
• Study First Posted: 2006-02-22
• Status Verified: 2008-10
• Primary Completion: 2009-05
• Study Completion: 2011-01
• Last Update Submitted: 2021-05-12
• Last Update Posted: 2021-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Calcium channel blockers (amlodipine, azelnidipine)	Amlodipine
2	Calcium channel blockers (amlodipine, azelnidipine)	Azelnidipine

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Department of Cardiology, Juntendo University School of Medicine; 🇯🇵 Tokyo, Japan