Benefits of Medical Therapy Plus Stenting for Renal Atherosclerotic Lesions - Full Text View

Sponsored by:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00081731

Purpose

This study will compare medical therapy plus stenting of hemodynamically significant renal artery stenoses versus medical therapy alone in patients with systolic hypertension and renal artery stenosis.

Condition	Intervention	Phase
Atherosclerosis Cardiovascular Diseases Hypertension, Renovascular Renal Artery Obstruction	Drug: Atacand Procedure: Angioplasty plus stenting	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL)

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty High Blood Pressure

Drug Information available for: CV 11974 Candesartan cilexetil

U.S. FDA Resources

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:

Cardiovascular or renal death [ Time Frame: Measured at every 3 months for the first year and annually thereafter ] [ Designated as safety issue: Yes ]
Myocardial infarction [ Time Frame: Measured at every 3 months for the first year and annually thereafter ] [ Designated as safety issue: Yes ]
Hospitalization for congestive heart failure [ Time Frame: Measured at every 3 months for the first year and annually thereafter ] [ Designated as safety issue: Yes ]
Stroke [ Time Frame: Measured at every 3 months for the first year and annually thereafter ] [ Designated as safety issue: Yes ]
Doubling of serum creatinine levels [ Time Frame: Measured at every 3 months for the first year and annually thereafter ] [ Designated as safety issue: Yes ]
Need for renal replacement therapy [ Time Frame: Measured at every 3 months for the first year and annually thereafter ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1080
Study Start Date:	April 2004
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Optimal Medical Therapy: Active Comparator Optimal anti-hypertensive therapy	Drug: Atacand Atacand and caduet or optimal medical therapy for hypertension
Stenting: Experimental Stent procedure plus optimal anti-hypertensive therapy	Procedure: Angioplasty plus stenting Angioplasty plus stenting of the renal artery

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

INCLUSION CRITERIA:

Documented history of hypertension on two or more anti-hypertensive medications OR renal dysfunction, defined as Stage 3 or greater chronic kidney disease (CKD) based on the new National Kidney Foundation (NKF) classifications (estimated glomerular filtration rate [GFR] less than 60 mL per minute per 1.73 m^2, calculated by the modified Modification of Diet in Renal Disease [MDRD] formula)
One or more severe renal artery stenoses by any of the following pathways:
1. Angiographic: greater than or equal to 60% and less than 100% by renal angiogram OR
2. Duplex: systolic velocity of greater than 300 cm/sec OR
3. Core lab approved magnetic resonance angiogram (MRA) (refer to the protocol for specific criteria)

EXCLUSION CRITERIA:

Refer to protocol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00081731

Locations

United States, Ohio
University of Toledo	Recruiting
Toledo, Ohio, United States, 43614
Contact: Holly Burtch, RN 419-383-6289 holly.burtch@utoledo.edu
Contact: Christopher Cooper, M.D.
Principal Investigator: Christopher J. Cooper, MD

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:	David Cohen, MD	Mid-America Heart Institute, St. Luke's Hospital, Kansas City, MO
Principal Investigator:	Christopher J. Cooper, MD	University of Toledo
Principal Investigator:	Donald Cutlip, MD	Beth Israel Deaconess Medcial Center
Principal Investigator:	Alan Matsumoto, MD	University of Virginia School of Medicine
Principal Investigator:	Michael Steffes, MD	University of Minnesota

More Information

Additional Information:

Click here for the CORAL trial website This link exits the ClinicalTrials.gov site

Publications:

Cooper CJ, Murphy TP, Matsumoto A, Steffes M, Cohen DJ, Jaff M, Kuntz R, Jamerson K, Reid D, Rosenfield K, Rundback J, D'Agostino R, Henrich W, Dworkin L. Stent revascularization for the prevention of cardiovascular and renal events among patients with renal artery stenosis and systolic hypertension: rationale and design of the CORAL trial. Am Heart J. 2006 Jul;152(1):59-66.

Murphy TP, Cooper CJ, Dworkin LD, Henrich WL, Rundback JH, Matsumoto AH, Jamerson KA, D'Agostino RB. The Cardiovascular Outcomes with Renal Atherosclerotic Lesions (CORAL) study: rationale and methods. J Vasc Interv Radiol. 2005 Oct;16(10):1295-300. No abstract available.

Responsible Party:	University of Toledo ( Christopher Cooper, MD )
Study ID Numbers:	161, U01 HL71556
Study First Received:	April 19, 2004
Last Updated:	April 10, 2009
ClinicalTrials.gov Identifier:	NCT00081731 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Atherosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Agents
Renal Artery Obstruction
Arteriosclerosis
Angiotensin II
Antihypertensive Agents

Hypertension, Renovascular
Angiotensin II Type 1 Receptor Blockers
Hypertension, Renal
Candesartan cilexetil
Urologic Diseases
Candesartan
Kidney Diseases
Hypertension

Additional relevant MeSH terms:

Atherosclerosis
Arterial Occlusive Diseases
Molecular Mechanisms of Pharmacological Action
Vascular Diseases
Cardiovascular Agents
Renal Artery Obstruction
Arteriosclerosis
Antihypertensive Agents
Pharmacologic Actions

Hypertension, Renovascular
Angiotensin II Type 1 Receptor Blockers
Hypertension, Renal
Candesartan cilexetil
Urologic Diseases
Therapeutic Uses
Cardiovascular Diseases
Kidney Diseases
Hypertension

ClinicalTrials.gov processed this record on September 10, 2009