Clinical trial NCT00294567: Azelnidipine Anti-Coronary Atherosclerotic Trial in Hypertensive Patients by Serial Volumetric IVUS Analysis(ALPS-J)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Coronary Atherosclerosis
Keywords: Hypertension
PCI
Calcium Channel Blockers
IVUS
Plaque
Lead sponsor: Juntendo University
Sponsor class: OTHER
Collaborators: name: Japan Heart Foundation
First posted: 2006-02-22
Enrollment: 199
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: 48Weeks
Secondary outcomes:
measure: 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.
timeFrame: 48Weeks
measure: 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)
timeFrame: 48Weeks
measure: 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.
timeFrame: 48Weeks
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Department of Cardiology, Juntendo University School of Medicine
Study officials:
affiliation: Director of Cardiology Professor of Medicine
name: HIROYUKI MD DAIDA
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.