Valsartan for Suppression of Plaque Volume and Restenosis After Drug-Eluting Stent (VAL-SUPPRES)
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Purpose
To evaluate that angiotensin-converting enzyme (ACE) inhibitors and angiotensin-converting enzyme receptor blockers (ARBs) reduce the risk of restenosis after DES implantation.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Drug: Valsartan |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Valsartan for SUPpression of Plaque Volume and Restenosis After Drug-Eluting Stent (The VAL-SUPPRESS TRial) |
- Angiographic in-stent late-loss (target vessel) [ Time Frame: at 8-month follow-up. ] [ Designated as safety issue: No ]
- 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 [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Composite of Major cardiac adverse events including death, Q-MI, Non Q-MI, and target lesion or vessel revascularization [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
- Each component of MACE [ Time Frame: 3 days in average ] [ Designated as safety issue: Yes ]3 day hospitalization is normal for index procedure and outcome needs to be measured at discharge.
- Each component of MACE [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Each component of MACE [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
- In-stent and in-segment restenosis rate [ Time Frame: 8 months ] [ Designated as safety issue: No ]
- In-segment late loss [ Time Frame: 8 months ] [ Designated as safety issue: No ]
- Percent atheroma volume of 10mm length by IVUS examination (non-target vessel) in IVUS-substudy [ Time Frame: 8 months ] [ Designated as safety issue: No ]
| Enrollment: | 220 |
| Study Start Date: | September 2006 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Valsartan treatment gorup
Valsartan 160mg per day group
|
Drug: Valsartan
Valsartan 160mg per day
|
|
No Intervention: No Valsartan treatment group
No valsartan treatment
|
Detailed Description:
Stimulation of the angiotensin II type 1 (AT1) receptors after arterial injury promotes vascular smooth muscle cell (VSMC) migration, proliferation, and extracellular matrix production, leading to the hope that blockade of this receptor by angiotensin-converting enzyme inhibitors (ACEI) or specific (AT1) receptor antagonists (ARBs) might reduce intimal hyperplasia. However, despite confirmatory evidence in several animal models of restenosis, the large scale MERCATOR and MARCATOR trials of cilazapril with balloon angioplasty failed to show benefit. In 1999, Kondo reported the results of a randomized pilot trial of 100 patients who received Palmaz-Schatz stents and were randomized to receive the ACE inhibitor quinapril or placebo. The volume of neointimal hyperplasia assessed by IVUS was significantly less quinapril than the control group (18 ± 0.6 mm3 vs. 25 ± 0.6 mm3; p < 0.05). The quinapril group's restenosis rate was 16%, with the quinapril benefit being observed only in patients with the D/D and I/D genotypes. Also, other study reported on a consecutively treated cohort of 1,598 stented patients, noting that ACE inhibitor usage at the time and after stenting reduced the risk of subsequent revascularization dramatically (adjusted odds ratio, 0.46; p = 0.001). In the ValPREST trial which is a single-center randomized trial of patients receiving stents for type B2/C lesions, comparing valsartan (and ARV) 80 mgs daily with open treatment, patients randomized to valsartan had a 19% incidence of restenosis compared with 39% in the open treatment arm (p = 0.005).
Recently, several randomized studies were conducted to compare the safety and efficacy of the two leading drug-eluting stent (DES). However, data on the association of ARBs for suppression of neointimal hyperplasia are limited in the DES era. Therefore, a pivotal randomized study is warranted.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
1) 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
2) Non-significant non-ischemic intermediate narrowing (non-target vessel)
- Percent diameter stenosis 20%~50% by visual estimate
- No objective evidence of ischemia
Exclusion Criteria:
- 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
Contacts and Locations| Korea, Republic of | |
| Asan Medical Center | |
| Seoul, Korea, Republic of, 138-736 | |
| Samsung Medical Center | |
| Seoul, Korea, Republic of | |
| St. Mary's Catholic Medical Center | |
| Seoul, Korea, Republic of | |
| Yonsei University Medical Center | |
| Seoul, Korea, Republic of | |
| Ajou University Hospital | |
| Suwon, Korea, Republic of | |
| Principal Investigator: | Seung-Jung Park, MD, PhD | Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine |
More Information
No publications provided
| Responsible Party: | Seung-Jung Park, M.D., Ph.D.,Professor of Medicine Asan Medical Center, University of Ulsan, College of Medicine, CardioVascular Research Foundation, Korea |
| ClinicalTrials.gov Identifier: | NCT00589732 History of Changes |
| Other Study ID Numbers: | 2006-0077 |
| Study First Received: | December 31, 2007 |
| Last Updated: | August 7, 2012 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Keywords provided by CardioVascular Research Foundation, Korea:
|
stents angiotensin-converting enzyme |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
Valsartan Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on October 17, 2012
