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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seung-Jung Park
• Collaborator: Novartis
• Treatments: Valsartan

Criteria

Inclusion Criteria:

1. 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

2. Angiographic: Patients who have

1) Significant ischemic narrowing (target vessel)

1. De novo coronary lesion (no restriction of lesion length)

2. Percent diameter stenosis ≥50% by visual estimate

3. Reference vessel size ≥2.5 mm by visual estimation

4. Lesions suitable for stenting

And/Or

2) Non-significant non-ischemic intermediate narrowing (non-target vessel)

1. Percent diameter stenosis 20%~50% by visual estimate

2. No objective evidence of ischemia

Exclusion Criteria:

1. Patients received a Angiotensin converting enzyme inhibitor (ACE-I) or ACE-receptor blockers (ARBs) in the previous week prior to enrollment

2. History of bleeding diathesis or coagulopathy

3. Pregnant

4. Known hypersensitivity or contra-indication to contrast agent and heparin

5. Limited life-expectancy (less than 1 year)

6. Acute ST-elevation myocardial within 1 week

7. Characteristics of lesion 1) Left main disease 2) In-stent restenosis 3) Graft vessels

8. Hematological disease (Neutropenia <3000/mm3, Thrombocytopenia <100,000/mm3)

9. Hepatic dysfunction, liver enzyme (ALT and AST) elevation >3 times normal

10. Renal dysfunction, creatinine >2.0mg/dL

11. Contraindication to aspirin and clopidogrel