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

NCT00294567 | Completed Phase 4

• 1 other identifier: JHF-17NOV2005
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

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).

Conditions

Hypertension; Coronary Atherosclerosis

Keywords

Hypertension; PCI; Calcium Channel Blockers; IVUS; Plaque

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

Amlodipine

Drug: Calcium channel blockers (amlodipine, azelnidipine)

2

ACTIVE COMPARATOR

Azelnidipine

Drug: Calcium channel blockers (amlodipine, azelnidipine)

Interventions

Calcium channel blockers (amlodipine, azelnidipine) DRUG

Drug: amlodipine Drug: azelnidipine

1; 2

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Juntendo University: lead
• Japan Heart Foundation: collaborator

Study Sites (1)

Department of Cardiology, Juntendo University School of Medicine

Tokyo, Japan

Location

Related Publications (2)

• 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.

  PMID: 23214115 DERIVED

• 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.

  PMID: 21471671 DERIVED

MeSH Terms

Conditions

Hypertension; Coronary Artery Disease; Plaque, Amyloid

Interventions

Calcium Channel Blockers; Amlodipine; azelnidipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Cardiovascular Agents; Therapeutic Uses; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• HIROYUKI MD DAIDA

  Director of Cardiology Professor of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2006
• First Posted: February 22, 2006
• Study Start: December 1, 2005
• Primary Completion: May 1, 2009
• Study Completion: January 1, 2011
• Last Updated: May 14, 2021

Record last verified: 2008-10

Locations

JP (1)