The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions
NCT ID: NCT00823212
Last Updated: 2019-03-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1530 participants
INTERVENTIONAL
2009-01-31
2014-12-31
Brief Summary
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This clinical trial compares outcomes in patients treated with PROMUS Element to those in patients treated with a different everolimus-eluting coronary stent. The lesions are of average length in average-sized vessels ("workhorse"). A companion sub-trial evaluates outcomes in smaller vessels (SV) and another sub-trial evaluates outcomes in longer lesions (LL).
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Detailed Description
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During the trial, thienopyridines must be administered according to the 2007 American College of Cardiology (ACC)/American Heart Association (AHA)/Society for Cardiovascular Angiography and Interventions (SCAI) guidelines, which recommended that clopidogrel (75 mg daily) or ticlopidine (250 mg twice daily) be prescribed after stent implantation for at least 6 months in all patients, and for at least 12 months in patients who are not at high risk of bleeding. For sites in the United States, the use of prasugrel is not allowed as part of the PLATINUM Clinical Trial. For sites in other countries, prasugrel may be prescribed according to its approved dosing in countries in which it is available. For patients taking aspirin daily a loading dose is recommended; for patients who have not been taking aspirin daily, aspirin must be administered as a loading dose. Patients continue to take aspirin indefinitely to reduce the risk of thrombosis.
The main study is the PLATINUM Workhorse Randomized Controlled Trial, which is registered under NCT00823212. The clinical protocol includes two companion sub-trials with smaller vessels (PLATINUM SV) and longer lesions (PLATINUM LL) plus a Pharmacokinetics sub-trial (PLATINUM PK). The three sub-trials are registered under separate NCT numbers.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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PROMUS
Patients who received the PROMUS (XIENCE V) Everolimus-Eluting Coronary Stent
PROMUS Coronary Stent System
PROMUS is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
Aspirin
Patients are required to take aspirin indefinitely after stent implant. It is recommended that aspirin 162-325 mg daily be given for at least 6 months after stent placement and that aspirin 75-162 mg daily be given indefinitely thereafter.
Thienopyridine
Patients must be treated with one of the following thienopyridines for at least 6 months following the index procedure: clopidogrel 75 mg daily; or ticlopidine 250 mg twice daily; or prasugrel (outside the United States and if approved at the time of the procedure). If used, the prescribed dose should be in accordance with approved country-specific labeling. In patients not at high risk of bleeding, thienopyridine treatment should continue for at least 12 months after stent implant.
PROMUS Element
Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
PROMUS Element Coronary Stent System
PROMUS Element is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating that is the same as on the PROMUS \[XIENCE V\] stent).
Aspirin
Patients are required to take aspirin indefinitely after stent implant. It is recommended that aspirin 162-325 mg daily be given for at least 6 months after stent placement and that aspirin 75-162 mg daily be given indefinitely thereafter.
Thienopyridine
Patients must be treated with one of the following thienopyridines for at least 6 months following the index procedure: clopidogrel 75 mg daily; or ticlopidine 250 mg twice daily; or prasugrel (outside the United States and if approved at the time of the procedure). If used, the prescribed dose should be in accordance with approved country-specific labeling. In patients not at high risk of bleeding, thienopyridine treatment should continue for at least 12 months after stent implant.
Interventions
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PROMUS Coronary Stent System
PROMUS is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Coronary Stent System
PROMUS Element is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating that is the same as on the PROMUS \[XIENCE V\] stent).
Aspirin
Patients are required to take aspirin indefinitely after stent implant. It is recommended that aspirin 162-325 mg daily be given for at least 6 months after stent placement and that aspirin 75-162 mg daily be given indefinitely thereafter.
Thienopyridine
Patients must be treated with one of the following thienopyridines for at least 6 months following the index procedure: clopidogrel 75 mg daily; or ticlopidine 250 mg twice daily; or prasugrel (outside the United States and if approved at the time of the procedure). If used, the prescribed dose should be in accordance with approved country-specific labeling. In patients not at high risk of bleeding, thienopyridine treatment should continue for at least 12 months after stent implant.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient (or legal guardian) understands study requirements and treatment procedures and provides written informed consent before any study-specific tests or procedures are performed
* For patients less than 20 years of age enrolled at a Japanese site, patient and patient's legal representative must provide written informed consent before any study-specific tests or procedures are performed
* Patient is eligible for percutaneous coronary intervention (PCI)
* Patient has documented stable angina pectoris or documented silent ischemia; or unstable angina pectoris
* Patient is an acceptable candidate for coronary artery bypass grafting (CABG)
* Patient has a left ventricular ejection fraction (LVEF) \>=30% as measured within 30 days prior to enrollment
* Patient is willing to comply with all protocol-required follow-up evaluations
\- Target lesion must be a de novo lesion located in a native coronary artery with a visually estimated reference vessel diameter (RVD) \>=2.50 mm and \<=4.25 mm. Target lesion length must measure (by visual estimate) \<=24 mm. Target lesion must be in a major coronary artery or branch with visually estimated stenosis \>=50% and \<100% with Thrombolysis in Myocardial Infarction (TIMI) flow \>1.
Exclusion Criteria
* Patient has had a known diagnosis of recent MI (ie, within 72 hours prior to index procedure) and has elevated enzymes at time of index procedure as follows.
* Patients are excluded if any of the following criteria are met at time of the index procedure.
* If creatine kinase-myoglobin band (CK-MB) \>2× upper limit of normal (ULN), the patient is excluded regardless of CK Total.
* If CK-MB is 1-2× ULN, the patient is excluded if the CK Total is \>2× ULN.
* If CK Total/CK MB are not used and Troponin is, patients are excluded if the following criterion is met at time of index procedure.
* Troponin \>1× ULN with at least one of the following.
* Patient has ischemic symptoms and ECG changes indicative of ongoing ischemia (eg, \>1 mm ST segment elevation or depression in consecutive leads or new left bundle branch block \[LBBB\]);
* Development of pathological Q waves in the ECG; or
* Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
Note: For patients with unstable angina or patients who have had a recent MI, CK Total/CK MB (or Troponin if CK Total/CK MB are not used) must be documented prior to enrolling/randomizing the patient.
* Patient has received an organ transplant or is on a waiting list for an organ transplant
* Patient is receiving or scheduled to receive chemotherapy within 30 days before or after index procedure
* Patient is receiving oral or intravenous immunosuppressive therapy (ie, inhaled steroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (eg, human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)
* Patient is receiving chronic (\>=72 hours) anticoagulation therapy (eg, heparin, coumadin) for indications other than acute coronary syndrome
* Patient has platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3
* Patient has white blood cell (WBC) count \<3,000 cells/mm3
* Patient has documented or suspected liver disease, including laboratory evidence of hepatitis
* Patient is on dialysis or has known renal insufficiency (ie, estimated creatinine clearance \<50 ml/min by the Cockcroft Gault formula, or \[(140-age)\*lean body weight (in kg)\]/\[plasma creatinine (mg/dl)\*72\])
* Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions
* Patient has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within past 6 months, or has any permanent neurologic defect that may cause non-compliance with the protocol
* Target vessel(s) or side branch has been treated with any type of PCI (eg, balloon angioplasty, stent, cutting balloon, atherectomy) within 12 months prior to index procedure
* Target vessel(s) has been treated within 10 mm proximal or distal to target lesion (by visual estimate) with any type of PCI (eg, balloon angioplasty, stent, cutting balloon, atherectomy) at any time prior to index procedure
* Non-target vessel or side branch has been treated with any type of PCI (eg, balloon angioplasty, stent, cutting balloon, atherectomy) within 24 hours prior to index procedure
* Planned or actual target vessel(s) treatment with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon, or transluminal extraction catheter immediately prior to stent placement
* Planned PCI or CABG after index procedure
* Patient previously treated at any time with coronary intravascular brachytherapy
* Patient has a known allergy to the study stent system or protocol-required concomitant medications (eg, stainless steel, platinum, cobalt, chromium, nickel, tungsten, acrylic, fluoropolymers, everolimus, thienopyridines, aspirin, contrast) that cannot be adequately premedicated
* Patient has active peptic ulcer or active gastrointestinal (GI) bleeding
* Patient has one of the following.
* Other serious medical illness (eg, cancer, congestive heart failure) that may reduce life expectancy to less than 24 months
* Current problems with substance abuse (eg, alcohol, cocaine, heroin, etc.)
* Planned procedure that may cause non-compliance with protocol or confound data interpretation
* Patient is participating in another investigational drug or device clinical trial that has not reached its primary endpoint
* Patient intends to participate in another investigational drug or device clinical trial within 12 months after index procedure
* Patient with known intention to procreate within 12 months after index procedure (Women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure.)
* Patient is a woman who is pregnant or nursing (A pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential)
* Patient has more than 2 target lesions, or more than 1 target lesion and 1 non-target lesion, which will be treated during the index procedure
* Target lesion meets any of the following criteria:
* Aorto-ostial location (ie, lesion located within 5 mm of ostium by visual estimate)
* Left main location
* Located within 5 mm of origin of the left anterior descending (LAD) coronary artery or left circumflex (LCX) coronary artery by visual estimate
* Located within a saphenous vein graft or arterial graft
* Will be accessed via a saphenous vein graft or arterial graft
* Involves a side branch \>=2.0 mm in diameter by visual estimate
* Involves a clinically significant side branch \<2.0 mm in diameter by visual estimate that has a clinically significant stenosis at the ostium
* TIMI flow 0 (total occlusion) or TIMI flow 1 prior to wire crossing
* Excessive tortuosity proximal to or within the lesion
* Extreme angulation proximal to or within the lesion
* Target lesion and/or target vessel proximal to the target lesion is moderately to severely calcified by visual estimate
* Restenotic from previous intervention
* Thrombus, or possible thrombus, present in target vessel
* Non-target lesion to be treated during the index procedure meets any of the following criteria:
* Located within the target vessel
* Located within a bypass graft (venous or arterial)
* Left main location
* Chronic total occlusion
* Involves a complex bifurcation (eg, bifurcations requiring treatment with more than 1 stent)
* Restenotic from previous intervention
* Patient has unprotected left main coronary artery disease (\>50% diameter stenosis)
* Patient has protected left main coronary artery disease and a target lesion in the LAD or LCX
* Patient has an additional clinically significant lesion(s) in target vessel for which an intervention within 12 months after the index procedure is likely to be required
* Patient has 2 target lesions in the same vessel that are separated by less than 15 mm (by visual estimate) Note: Multiple focal stenoses will be considered as a single lesion if they can be completely covered with 1 stent.
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Peter M Maurer, MPH
Role: STUDY_DIRECTOR
Boston Scientific Corporation
Locations
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Baptist Medical Center Princeton
Birmingham, Alabama, United States
Banner Good Samaritan Regional Medical Center
Phoenix, Arizona, United States
Arkansas Heart Hospital
Little Rock, Arkansas, United States
Bakersfield Memorial Hospital
Bakersfield, California, United States
Scripps Clinic
La Jolla, California, United States
Good Samaritan Hospital
Los Angeles, California, United States
University of California Davis Medical Center
Sacramento, California, United States
Mercy General Hospital
Sacramento, California, United States
University of California San Diego
San Diego, California, United States
Alvarado Hospital
San Diego, California, United States
South Denver Cardiology Associates, PC
Littleton, Colorado, United States
Medical Center of the Rockies (Loveland)
Loveland, Colorado, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
MediQuest Research Group Inc. at Munroe Regional Medical Center
Ocala, Florida, United States
Florida Hospital
Orlando, Florida, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, United States
Medical Center of Central Georgia
Macon, Georgia, United States
Southern Illinois University Memorial Medical Center
Springfield, Illinois, United States
St. John's Hospital
Springfield, Illinois, United States
Krannert Institute of Cardiology
Indianapolis, Indiana, United States
St. Vincent's Hospital
Indianapolis, Indiana, United States
Mercy Hospital Medical Center
Des Moines, Iowa, United States
Jewish Hospital and St. Mary's Healthcare
Louisville, Kentucky, United States
Maine Medical Center
Portland, Maine, United States
Union Memorial Hospital
Baltimore, Maryland, United States
Washington Adventist Hospital
Takoma Park, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
Genesys Regional Medical Center
Grand Blanc, Michigan, United States
Spectrum Health Hospitals
Grand Rapids, Michigan, United States
Northern Michigan Hospital
Petoskey, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
St. Mary's Duluth Clinic Regional Heart Center
Duluth, Minnesota, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Mayo Clinic Foundation
Rochester, Minnesota, United States
North Mississippi Medical Center
Tupelo, Mississippi, United States
St. Luke's Hospital / Mid America Heart Institute
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Nebraska Heart Institute
Lincoln, Nebraska, United States
Cooper Hospital/University Medical Center
Camden, New Jersey, United States
Our Lady of Lourdes Medical Center
Camden, New Jersey, United States
Maimonides Medical Center
Brooklyn, New York, United States
Kaleida Health
Buffalo, New York, United States
Mount Sinai School Medical Center
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
St. Francis Hospital
Roslyn, New York, United States
Moses H. Cone Memorial Hospital/LeBauer Cardiovascular Research Foundation
Greensboro, North Carolina, United States
Wake Medical Center
Raleigh, North Carolina, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio, United States
Good Samaritan Hospital
Cincinnati, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Ohio Health Research and Innovation Institute
Columbus, Ohio, United States
Firelands Regional Medical Center
Sandusky, Ohio, United States
Mercy St. Vincent Medical Center
Toledo, Ohio, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Lankenau Institute for Medical Research
Bryn Mawr, Pennsylvania, United States
Pinnacle Health at Harrisburg Hospital
Harrisburg, Pennsylvania, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
Sisters of Charity Providence Hospital
Columbia, South Carolina, United States
Jackson-Madison County General Hospital
Jackson, Tennessee, United States
Baptist Memorial Hospital
Memphis, Tennessee, United States
Heart Hospital of Austin
Austin, Texas, United States
Baylor Heart & Vascular Hospital
Dallas, Texas, United States
St. Luke's Episcopal Hospital
Houston, Texas, United States
Methodist Texsan Hospital
San Antonio, Texas, United States
Trinity Mother Frances Health System
Tyler, Texas, United States
Lynchburg General Hospital
Lynchburg, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Deaconess Medical Center
Spokane, Washington, United States
Providence Health & Services - Washington
Spokane, Washington, United States
Aspirus Heart and Vascular Institute - Research and Education
Wausau, Wisconsin, United States
Monash Medical Centre
Clayton, Victoria, Australia
St. Vincent's Hospital
Fitzroy, Victoria, Australia
Royal Perth Hospital
Perth, , Australia
The Prince Charles Hospital
Queensland, , Australia
Allgemeines Krankenhauas AKH
Vienna, , Austria
Academisch Ziekenhuis Middelheim
Antwerp, , Belgium
Ziekenhuis Oost Limburg
Genk, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
UZ Gasthuisberg
Leuven, , Belgium
Skejby Sygehus
Aarhus, , Denmark
Rigshospitalet Copenhagen
Copenhagen, , Denmark
Oulu University Hospital
Oulu, , Finland
Tampere University Hospital
Tampere, , Finland
Turku University Hospital
Turku, , Finland
CHU de Besancon
Besançon, , France
Clinique St. Augustin
Bordeaux, , France
Institut Cardiovasculaire - Paris Sud / Institut Hospitalier Jacques Cartier
Massy, , France
Clinique du Millenaire
Montpellier, , France
Centre Hopital Universitaire Rangueil
Toulouse, , France
Clinique Pasteur
Toulouse, , France
Kerckhoff Klinik
Bad Nauheim, , Germany
Herz-und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen, , Germany
Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH
Bad Segeberg, , Germany
Universitatsklinik Charite Berlin
Berlin, , Germany
Universitat Heidelberg
Heidelberg, , Germany
Herzzentrum Universitat Leipzig
Leipzig, , Germany
Kokura Memorial Hospital
Kitakyushu-shi, Fukuoka, Japan
Japan Community Health Care Organization Hokkaido Hospital
Sapporo, Hokkaido, Japan
Shonan Kamakura General Hospital
Kamakura-shi, Kanagawa, Japan
Saiseikai Yokohama-City Eastern Hospital
Yokohama, Kanagawa, Japan
Sakakibara Heart Institute, Japan Research Promotion Society for Cardiovascular Diseases
Fuchu-shi, Tokyo, Japan
Teikyo University Hospital
Itabashi-ku, Tokyo, Japan
Toho University Ohashi Medical Center
Meguro-ku, Tokyo, Japan
The Cardiovascular Institute Hospital
Minato-ku, Tokyo, Japan
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, Japan
Sakurabashi Watanabe Hospital
Osaka, , Japan
P. Stradins University Hospital
Riga, , Latvia
Sarawak General Hospital
Kota Samarahan, Sarawak, Malaysia
Institut Jantung Negara
Kuala Lumpur, , Malaysia
Medisch Centrum Alkmaar
Alkmaar, , Netherlands
Amphia Ziekenhuis
Breda, , Netherlands
Catherina Ziekenhuis
Eindhoven, , Netherlands
St Antonius Ziekenhuis
Nieuwegein, , Netherlands
Middlemore Hospital
Otahuhu, Auckland, New Zealand
Ascot Angiography
Auckland, , New Zealand
Wellington Hospital
Wellington, , New Zealand
Szpital Uniwersytecki
Bydgoszcz, , Poland
SPZOZ Szpital Uniwersytecki w Krakowie
Krakow, , Poland
National Institute of Cardiology
Warsaw, , Poland
Military Hospital
Wroclaw, , Poland
Hospital De Santa Cruz
Carnaxide, , Portugal
National Heart Centre Singapore
Singapore, , Singapore
Guys and St. Thomas NHS Foundation Trust St. Thomas Hospital
London, England, United Kingdom
James Cook University Hospital
Middlesbrough, England, United Kingdom
John Radcliffe Infirmary Oxford II
Oxford, England, United Kingdom
Royal Victoria Hospital
Belfast, Ireland, United Kingdom
Golden Jubilee National Hospital
Clydebank, , United Kingdom
Southampton University Hospital
Southampton, , United Kingdom
Countries
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References
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Stone GW, Teirstein PS, Meredith IT, Farah B, Dubois CL, Feldman RL, Dens J, Hagiwara N, Allocco DJ, Dawkins KD; PLATINUM Trial Investigators. A prospective, randomized evaluation of a novel everolimus-eluting coronary stent: the PLATINUM (a Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System [PROMUS Element] for the Treatment of Up to Two de Novo Coronary Artery Lesions) trial. J Am Coll Cardiol. 2011 Apr 19;57(16):1700-8. doi: 10.1016/j.jacc.2011.02.016. Epub 2011 Apr 4.
Kelly CR, Teirstein PS, Meredith IT, Farah B, Dubois CL, Feldman RL, Dens J, Hagiwara N, Rabinowitz A, Carrie D, Pompili V, Bouchard A, Saito S, Allocco DJ, Dawkins KD, Stone GW. Long-Term Safety and Efficacy of Platinum Chromium Everolimus-Eluting Stents in Coronary Artery Disease: 5-Year Results From the PLATINUM Trial. JACC Cardiovasc Interv. 2017 Dec 11;10(23):2392-2400. doi: 10.1016/j.jcin.2017.06.070.
Other Identifiers
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ACTRN12608000582358
Identifier Type: -
Identifier Source: secondary_id
S2046
Identifier Type: -
Identifier Source: org_study_id
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