PLATINUM Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions-Pharmacokinetics (PLATINUM PK)

NCT01510327 | Completed Phase 3 Results DMC

• 1 other identifier: S2046B
• Study Type: interventional
• Target: 22
• Locations: 2 countries
• Sites: 5

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of the PROMUS Element™ Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo atherosclerotic coronary artery lesions. The lesions are located in vessels that are average-sized.

Conditions

Coronary Artery Disease

Keywords

drug-eluting stents; DES; atherosclerotic

Outcome Measures

Primary Outcomes (1)

• Maximum Observed Everolimus Blood Concentration (Cmax)

  Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent

  Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours

Secondary Outcomes (13)

• Area Under the Concentration Versus Time Curve (AUC 0-t) Everolimus

  Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours

• Area Under the Concentration Versus Time Curve (AUC 0-24), Everolimus

  Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours

• Area Under the Concentration Versus Time Curve (AUC 0-infinity) Everolimus

  Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours

• Time of Occurrence of Maximum Everolimus Concentration (Tmax)

  Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours

• Terminal Phase Half-life (t1/2) Everolimus

  Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours

Study Arms (1)

PROMUS Element

EXPERIMENTAL

Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique. Total loaded dose of everolimus per stent is dependent on stent size and in this study the administered dose ranged from 60.1 µg to 138.6 µg per stent. Note that the total dose of everolimus administered to a patient is based on the number of stents received and the size of the stent(s). The total dose received per patient ranged from 60.1 µg to 197.8 µg.

Device: PROMUS Element Everolimus-Eluting Coronary Stent System; Drug: Aspirin; Drug: Thienopyridine

Interventions

PROMUS Element Everolimus-Eluting Coronary Stent System DEVICE

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).

PROMUS Element

Aspirin DRUG

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.

PROMUS Element

Thienopyridine DRUG

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.

Also known as: A brand name for clopidogrel is PLAVIX., A brand name for ticlopidine is TICLID.

PROMUS Element

Eligibility Criteria

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

You may qualify if:

• Patient must be at least 18 years of age
• 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.

You may not qualify if:

• Patient has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute myocardial infarction (MI)
• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (5)

Medical Center of the Rockies (Loveland)

Loveland, Colorado, 80538, United States

Location

Cardiac & Vascular Research Center of Northern Michigan

Petoskey, Michigan, 49770, United States

Location

Saiseikai Yokohama-City Eastern Hospital

Yokohama, Kanagawa, Japan

Location

Sakakibara Heart Institute, Japan Research Promotion Society for Cardiovascular Diseases

Fuchu-shi, Tokyo, Japan

Location

Tokyo Women's Medical University Hospital

Shinjuku-ku, Tokyo-to, Japan

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Aspirin; thienopyridine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Ruth Starzyk, PhD
• Organization: Boston Scientific

ruth.starzyk@bsci.com

508-683-6577

Study Officials

• Peter M. Maurer, MPH

  Boston Scientific Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2011
• First Posted: January 16, 2012
• Study Start: October 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: May 1, 2015
• Last Updated: March 26, 2019
• Results First Posted: April 5, 2012

Record last verified: 2019-03

Locations

JP (3); US (2)