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Type 2 DiabetesTuxedoNCT03125772

Trial on Safety & Performance of TAXUS Element vs. XIENCE Prime Stent in Treatment of Coronary Lesion in Diabetics

A study testing TAXUS Element™ Paclitaxel-Eluting Stent System and Xience PRIME Everolimus-Eluting Stent System in people with Type 2 Diabetes and Coronary Heart Disease, run by Fortis Escorts Heart Institute at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The TUXEDO-India is a prospective, single blind, multi-center randomized clinical trial to assess the TAXUS Element™ in a consecutive population of diabetic patients with coronary artery disease undergoing coronary revascularization. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes, Coronary Heart Disease
What is being tested?
TAXUS Element™ Paclitaxel-Eluting Stent System and Xience PRIME Everolimus-Eluting Stent System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,830 participants
Where
1 siteIndia
Study dates
Jun 2011to May 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • CI1. Patient must have a diagnosis of diabetes mellitus (Type 1 or Type 2) defined according to the American Diabetes Association as history of one of the followings :
  • Two hour plasma glucose >200 mg/dL (11.1 mmol/L) following a 75g oral glucose tolerance test
  • Random plasma glucose >200 mg/dL 3. A fasting plasma glucose level >126 mg/dL (7.0 mmol/L)
  • 4. Elevated HbA1c level 6.5 And currently undergoing pharmacological treatment 5.Patients admitted with ACS NSTEMI and HbA1c > 7 can be included even if they were not on pharmacological treatment. CI2. Patient (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed CI3. Patient is eligible for percutaneous coronary intervention (PCI) CI4. Patient has symptomatic coronary artery disease or documented silent ischemia. CI5. Patient is willing to comply with all protocol-required follow-up evaluations.
  • Angiographic Inclusion Criteria (visual estimate)
  • AI1. Target lesion must be a de novo lesion located in a native coronary artery with a visually estimated reference vessel diameter (RVD) 2.25 mm and 4.0 mm. Treatment of up to 3 de novo target lesions is allowed with a maximum of two denovo target lesions per epicardial vessel.
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  • AI2. Target lesion length must measure 34 mm (by visual estimate) AI3. 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. AI4. If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria. AI5. Non-study percutaneous intervention for lesions in a target vessel (including side branches) is allowed if performed 9 months prior to the index procedure. AI6. Non study percutaneous interventions for lesions in a non target vessel are allowed in the following circumstances:
  • Unsuccessful, or complicated bare metal stent, balloon dilatation, cutting balloon, atherectomy, thrombectomy, and laser treatments are allowed if performed 30 days prior to the index procedure.
  • Drug-eluting stent treatment is permitted if performed 90 days prior to index procedure. AI7. Non study, percutaneous interventions for lesion(s) in a target vessel (including side branches) or non-target vessel are allowed if performed 9 months after the index procedure.

Who cannot join

  • CE1. Patient has known allergy to the study stent system or protocol-required concomitant medications (e.g., stainless steel, platinum, chromium, nickel, iron, thienopyridines, aspirin, radiographic contrast medium) that cannot be adequately pre-medicated. CE2. Patient has any other serious medical illness (e.g., cancer, congestive heart failure) that may reduce life expectancy to less than 12 months CE3. Acute or chronic renal dysfunction (creatinine > 2.0 mg/dl or 177 μmol/l) CE4. Currently participating in another investigational drug or device study
  • Angiographic Exclusion Criteria (visual estimate)
  • AE1. Target lesion meets any of the following criteria:
  • Left main location including left main ostial location
  • Located within 2 mm of the 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 an arterial graft or distal to a diseased arterial or saphenous vein graft. Diseased graft defined as irregularity per angiogram and any visually estimated diameter stenosis > 20%.
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  • Involves a bifurcation in which the side branch 2.0 mm in diameter AND the ostium of the side branch is > 50% stenosed by visual estimate.
  • Involves a side branch requiring pre-dilatation
  • TIMI flow 0 (total occlusion) prior to guide wire crossing
  • Excessive tortuosity proximal to or within the lesion
  • Extreme angulation ( ≥90°) 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 the target vessel AE2. Patient has an additional clinically significant lesion(s) in the target vessel for which an intervention within 9 months after the index procedure may be required

Trial locations and contacts

1 site in 1 country.

India1 site

  • Fortis Escorts Heart Institute

    New Delhi, National Capital Territory of Delhi, 110025

Other trials in India

About this study

Official title: A Prospective, Single Blind, Multi-center, Randomized Trial to Compare the TAXUS Element™ Coronary Stent System Against the XIENCE Prime™ Coronary Stent System in the Treatment of a Diabetic Patient PopulatiOn in India

The TUXEDO-India is a prospective, single blind, multi-center randomized clinical trial to assess the TAXUS Element™ in a consecutive population of diabetic patients with coronary artery disease undergoing coronary revascularization. Approximately 1,830 patients with single or multi lesion, multi vessel coronary artery or saphenous vein graft disease ranging in vessels ranging from 2.25 mm to 4.0 mm in diameter by visual estimate will be enrolled in a 1:1 randomization to TAXUS Element™ vs. XIENCE™ Prime in India at up to 50 clinical sites, to demonstrate the safety and effectiveness of TAXUS Element™ in an unrestricted population.

Procedural Endpoints:

  • Device success, defined as attainment of < 30% residual stenosis of the target lesion (visual assessment) using the TAXUS Element™ or XIENCE™ Prime stent.
  • Lesion success defined as attainment of < 30% residual stenosis (visual assessment) using any percutaneous method.
  • Procedure success defined as lesion success without the occurrence of in-hospital MACE.
  • Procedure complication rate including composite and individual angiographic occurrence of dissection ≥B, distal embolization, no reflow, slow flow, abrupt closure, or perforation.
Read the detailed description

Primary Endpoint:

Composite safety endpoint of Target Vessel Failure (TVF) rate at 12 months post-index procedure:

  • Cardiac Death related to target vessel
  • Target Vessel Myocardial Infarction (TV-MI)
  • Target Vessel Revascularization (TVR)

Secondary Endpoint:

Clinical endpoints measured at 30, 180 days, and 1 and 2 years post index procedure:

  • TVF rate (primary endpoint 1 year)
  • Target Vessel Revascularization (TVR) rate
  • Target Lesion Revascularization (TLR)
  • Composite of cardiac death or target vessel MI
  • Composite of all deaths, all MI, all revascularizations
  • Major Adverse Cardiac Events (MACE) which is the composite endpoint of cardiac death, all myocardial infarction, and TLR
  • MI (Q-wave and non-Q-wave) rate
  • Cardiac death rate
  • Non-cardiac death rate
  • All death rate
  • Cardiac death or MI rate
  • All death or MI rate
  • Stent thrombosis rate (definite or probable by Academic Research Consortium [ARC] definitions)

Periprocedural endpoints:

  • Technical success rate
  • Clinical procedural success rate

Anti-platelet Therapy

A loading dose of either Clopidogrel (300mg, 600mg recommended), Ticlopidine (500mg), or Prasugrel (60mg) must be given to the patient prior to index procedure. Thereafter, Clopidogrel (75mg daily), Ticlopidine (250mg twice daily), Prasugrel (10mg) must be given for at least 12 months after stent implantation. If the protocol mandated (loading and or daily) dosage conflicts with local DFU, the local DFU should take precedence. Aspirin (ASA): Must be administered concomitantly with Clopidogrel, Ticlopidine or Prasugrel and then continued indefinitely

Sample Size Parameters:

The expected 12 month TVF rate for both groups is estimated to be 8.4% based on the data available from the SPIRIT IV trial. Given the non-inferiority margin (delta) of 4% with equal expected means and a one-sided 5% significance level, 824 patients in each group will provide at least 90% power to reject the null hypothesis if it is false. When allowance is made for 10% attrition, approximately 915 patients are required per each treatment group. Therefore, the necessary total sample size for the trial is 1,830 patients.

Being tested
TAXUS Element™ Paclitaxel-Eluting Stent System, Xience PRIME Everolimus-Eluting Stent System
Keywords
coronary artery disease, diabetes mellitus, everolimus, paclitaxel stents
Medical subject headings
Diabetes Mellitus, Type 2, Coronary Disease, Coronary Artery Disease, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAXUS Element™ Paclitaxel-Eluting Stent SystemDevice

    Texus Element is the next generation Boston Scientific paclitexel-eluting coronary sten and received DCGI approval on April 13th, 2010.

  • Xience PRIME Everolimus-Eluting Stent SystemDevice

    The Everolimus-eluting stent manufactured and distributed by Abbott Vascular Santa Clara, CA, as Xience Prime.

Study groups in NCT03125772
Study groupRoleWhat they receive
TAXUS Element™ Paclitaxel-Eluting SystemExperimentalThe TAXUS® Element™ stent system is a multifunctional device providing a mechanical structure for vascular lumen support and a pharmacological agent targeted toward reducing or preventing the incidence of restenosis. The TAXUS Element™ stent is a balloon expandable, stainless steel platinum alloy stent, coated with paclitaxel in a slow-release system, pre-mounted on a high-pressure Monorail delivery catheter and is intended for use in the treatment of coronary artery disease. The pharmacological agent, paclitaxel, is incorporated into a triblock polymer matrix and applied to the surface of the stent. The polymer matrix provides controlled release of available paclitaxel. The TAXUS Element™ stent design is built upon the TAXUS Express and TAXUS Liberte design experience, but incorporates several improved stent design characteristics. The TAXUS Element™ stent also has a smaller tip profile, designed to enhance the ability to cross tighter and/or more complex lesions.
Receives: Device: TAXUS Element™ Paclitaxel-Eluting Stent System
XIENCE PRIME™ ™ Everolimus-Eluting Stent SystemActive comparatorThe everolimus-eluting stent (EES, manufactured and distributed by Abbott Vascular, Santa Clara, CA, as XIENCE PRIME™ ) is a balloon expandable stent manufactured from a flexible cobalt chromium alloy with a multicellular design and 0.0032-in strut thickness which is coated with a thin (7.8 μm) nonadhesive, durable, biocompatible acrylic polymer and fluorinated copolymer releasing everolimus. Everolimus [40-O-(2-hydroxyethyl)- rapamycin], a semisynthetic macrolide immunosuppressant, inhibits growth factor-stimulated cell proliferation by causing cell-cycle arrest in the late G1 stage, thereby suppressing neointimal formation. Comparative analysis in an in vivo rabbit aortoiliac model has shown more rapid endothelialization with the EES compared to SES, PES, and ZES.
Receives: Device: Xience PRIME Everolimus-Eluting Stent System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite safety endpoint of Target Vessel Failure (TVF) rate at 12 months post-index procedure: • Cardiac Death related to target vessel • Target Vessel Myocardial Infarction (TV-MI) • Target Vessel Revascularization (TVR)

    TVS is defined as any ischemia-driven revascularization of the target vessel( TVR), MI (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.

    Measured: 12 Months

Secondary outcomes (12)

  1. Target Lesion Revascularization (TLR) TVF rate (primary endpoint 1 year) Target Vessel Revascularization rate Target Lesion Revascularization Composite of cardiac death or target vessel

    Measured: Measured at 30,180 days,and 1 and 2 years post index procedure

  2. Ischemia Driven Target Lesion Revascularization (TLR) Rate TVF rate (primary endpoint 1 year) Target Vessel Revascularization rate Target Lesion Revascularization Composite of cardiac death or target vessel

    Measured: Measured at 30,180 days,and 1 and 2 years post index procedure

  3. Target Vessel Failure (TVF)

    Measured: Measured at 30,180 days,and 1 and 2 years post index procedure

  4. Ischemia Driven Target Vessel Revascularization (TVR)

    Measured: Measured at 30,180 days,and 1 and 2 years post index procedure

  5. Target Lesion Failure Rate

    Target Lesion Failure Rate defined as any ischemia-driven revascularization of the target lesion (TLR), MI (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel

    Measured: Measured at 30,180 days,and 1 and 2 years post index procedure

  6. Myocardial Infarction(MI) rate

    Q-wave and Non-Q-wave, cumulative and individual

    Measured: Measured at 30,180 days,and 1 and 2 years post index procedure

  7. Cardiac death rate

    Measured: Measured at 30,180 days,and 1 and 2 years post index procedure

  8. Non-Cardiac death rate

    Measured: Measured at 30,180 days,and 1 and 2 years post index procedure

  9. All death or MI rate

    Measured: Measured at 30,180 days,and 1 and 2 years post index procedure

  10. All Death / MI / TVR Rate

    Measured: Measured at 30,180 days,and 1 and 2 years post index procedure

  11. Major Adverse Cardiac Event (MACE)

    MACE defined as a composite of death, MI (Q-wave and non-Q-wave), emergent coronary artery bypass surgery (CABG), or target lesion revascularization (TLR) by repeat PTCA, or CABG.

    Measured: Measured at 30,180 days,and 1 and 2 years post index procedure

  12. Stent Thrombosis Rate

    Stent thrombosis(ST) rate defined using ARC definition of definite and probable stent thrombosis and categorized as early, late or very late.

    Measured: Measured at 30,180 days,and 1 and 2 years post index procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2017
  2. Study startJun 2011
  3. Primary completionMay 2015
  4. Study completionMay 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
1,830 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03125772
Sponsor's protocol ID
Tuxedo
Other IDs
CTRI/2011/06/001830
Acronym
Tuxedo
Status last verified
Apr 2017
First submitted
2 Sep 2015
Last updated
24 Apr 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • www.crf.org/crf/newsroom/news/news-archive/963-announcing-the-tct-2015-late-breaking-trials-and-first-report-investigations

Questions about this trial

What is this clinical trial studying?

A study testing TAXUS Element™ Paclitaxel-Eluting Stent System and Xience PRIME Everolimus-Eluting Stent System in people with Type 2 Diabetes and Coronary Heart Disease, run by Fortis Escorts Heart Institute at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite safety endpoint of Target Vessel Failure (TVF) rate at 12 months post-index procedure: • Cardiac Death related to target vessel • Target Vessel Myocardial Infarction (TV-MI) • Target Vessel Revascularization (TVR) (time frame: 12 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03125772, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2017.

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