Valsartan for Suppression of Plaque Volume and Restenosis After Drug-Eluting Stent

NCT00589732 | Completed Phase 4 DMC

• 1 other identifier: 2006-0077
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 5

Brief Summary

To evaluate that angiotensin-converting enzyme (ACE) inhibitors and angiotensin-converting enzyme receptor blockers (ARBs) reduce the risk of restenosis after DES implantation.

Conditions

Coronary Artery Disease

Keywords

stents; angiotensin-converting enzyme

Outcome Measures

Primary Outcomes (1)

• Angiographic in-stent late-loss (target vessel)

  at 8-month follow-up.

Secondary Outcomes (8)

• Composite of Major cardiac adverse events including death, Q-MI, Non Q-MI, and target lesion or vessel revascularization -Delta change in percent atheroma area and volume

  30 days

• Composite of Major cardiac adverse events including death, Q-MI, Non Q-MI, and target lesion or vessel revascularization

  9 months

• Each component of MACE

  3 days in average

• Each component of MACE

  30 days

• Each component of MACE

  9 months

Study Arms (2)

Valsartan treatment gorup

EXPERIMENTAL

Valsartan 160mg per day group

Drug: Valsartan

No Valsartan treatment group

NO INTERVENTION

No valsartan treatment

Interventions

Valsartan DRUG

Valsartan 160mg per day

Valsartan treatment gorup

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical 1) Patients with angina and documented ischemia or patients with documented silent ischemia 2) Patients who are eligible for intracoronary stenting 3) Age \>18 years, \<75 ages 4) Preserved left ventricular ejection fraction (\>40%) 5) Written informed consent to the study protocol 6) Patients with hemodynamic stability and appropriate blood pressure, which were suitable for administration of valsartan 160mg
• Angiographic: Patients who have
• \) Significant ischemic narrowing (target vessel)
• De novo coronary lesion (no restriction of lesion length)
• Percent diameter stenosis ≥50% by visual estimate
• Reference vessel size ≥2.5 mm by visual estimation
• Lesions suitable for stenting
• And/Or
• \) Non-significant non-ischemic intermediate narrowing (non-target vessel)
• Percent diameter stenosis 20%\~50% by visual estimate
• No objective evidence of ischemia

You may not qualify if:

• Patients received a Angiotensin converting enzyme inhibitor (ACE-I) or ACE-receptor blockers (ARBs) in the previous week prior to enrollment
• History of bleeding diathesis or coagulopathy
• Pregnant
• Known hypersensitivity or contra-indication to contrast agent and heparin
• Limited life-expectancy (less than 1 year)
• Acute ST-elevation myocardial within 1 week
• Characteristics of lesion 1) Left main disease 2) In-stent restenosis 3) Graft vessels
• Hematological disease (Neutropenia \<3000/mm3, Thrombocytopenia \<100,000/mm3)
• Hepatic dysfunction, liver enzyme (ALT and AST) elevation \>3 times normal
• Renal dysfunction, creatinine \>2.0mg/dL
• Contraindication to aspirin and clopidogrel

Sponsors & Collaborators

• Seung-Jung Park: lead
• Novartis: collaborator

Study Sites (5)

Asan Medical Center

Seoul, 138-736, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

St. Mary's Catholic Medical Center

Seoul, South Korea

Location

Yonsei University Medical Center

Seoul, South Korea

Location

Ajou University Hospital

Suwon, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Valsartan

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Seung-Jung Park, MD, PhD

  Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D., Ph.D.,Professor of Medicine Asan Medical Center, University of Ulsan, College of Medicine

Study Record Dates

• First Submitted: December 31, 2007
• First Posted: January 10, 2008
• Study Start: September 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: August 8, 2012

Record last verified: 2012-08

Locations

KR (5)