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Post-operative Treatment of Diabetic Peripheral Arterial Disease Guided by Platelet Reactivity Unit

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ClinicalTrials.gov Identifier: NCT02762864
Recruitment Status : Unknown
Verified May 2016 by Chi-Hsiao Yeh, Chang Gung Memorial Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : May 5, 2016
Last Update Posted : May 5, 2016
Sponsor:
Information provided by (Responsible Party):
Chi-Hsiao Yeh, Chang Gung Memorial Hospital

Tracking Information
First Submitted Date  ICMJE May 3, 2016
First Posted Date  ICMJE May 5, 2016
Last Update Posted Date May 5, 2016
Study Start Date  ICMJE May 2016
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2016)
  • Peak exercise time [ Time Frame: month 0,12,or Early Termination ]
    To compare the effects of PRU-guided versus non-PRU-guided treatment on changes in the leg peak exercise time over time (pre-revascularization and 12 months post-revascularization, or early termination ) during 12 months of therapy in patients with Peripheral Artery Disease who have undergone endovascular -/+ bypass surgery revascularization for moderate to severe claudication or ischemic rest pain.
  • Limb hemodynamics (Ankle Brachial Index or Great Toe Index) [ Time Frame: month 0,1,6,12,or Early Termination ]
    To compare the effects of PRU-guided versus non-PRU-guided treatment on changes in the Limb hemodynamics (Ankle Brachial Index or Great Toe Index) over time (pre-revascularization and at 1, 6, and 12 months post-revascularization) during 12 months of therapy in patients with Peripheral Artery Disease who have undergone endovascular -/+ bypass surgery revascularization for moderate to severe claudication or ischemic rest pain.
  • leg pain MRI perfusion measures [ Time Frame: month 0,4,12,or Early Termination ]
    To compare the effects of PRU-guided versus non-PRU-guided treatment on changes in the lower leg muscle GOLD perfusion measure over time (pre-revascularization, 4, and 12 months post-revascularization, or early termination ) during 12 months of therapy in patients with Peripheral Artery Disease who have undergone endovascular -/+ bypass surgery revascularization for moderate to severe claudication or ischemic rest pain.
  • Quality of life measures [ Time Frame: month 0,12,or Early Termination ]
    To compare the effects of PRU-guided versus non-PRU-guided treatment on changes in the quality of life over time (pre-revascularization and 12 months post-revascularization, or early termination ) during 12 months of therapy in patients with Peripheral Artery Disease who have undergone endovascular -/+ bypass surgery revascularization for moderate to severe claudication or ischemic rest pain.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2016)
  • Major lower leg events (above the ankle amputations, revascularization procedures) [ Time Frame: month1, 3, 6,9,12,or Early Termination ]
    To compare the effects of PRU-guided versus non-PRU-guided treatment on changes in the major lower limb events, including above ankle amputation, new ulceration, and revascularization procedures over time (pre-revascularization and 1, 3, 6, 9, 12 months post-revascularization, or early termination ) during 12 months of therapy in patients with Peripheral Artery Disease who have undergone endovascular -/+ bypass surgery revascularization for moderate to severe claudication or ischemic rest pain.
  • Major bleeding events [ Time Frame: month1, 3, 6,9,12,or Early Termination ]
    To compare the effects of PRU-guided versus non-PRU-guided treatment on changes in bleeding events analyzed using the Thrombolysis in Myocardial Infarction Study Group (TIMI), PLATO, Bleeding Academic Research Consortium (BARC) and International Society of Thrombosis and Haemostasis (ISTH) definitions over time (pre-revascularization and 1, 3, 6, 9, 12 months post-revascularization, or early termination ) during 12 months of therapy in patients with Peripheral Artery Disease who have undergone endovascular -/+ bypass surgery revascularization for moderate to severe claudication or ischemic rest pain.
  • leg pain (claudication) onset time [ Time Frame: month 0,12,or Early Termination ]
    To compare the effects of PRU-guided versus non-PRU-guided treatment on changes in the leg pain (claudication) onset time over time (pre-revascularization and 12 months post-revascularization, or early termination ) during 12 months of therapy in patients with Peripheral Artery Disease who have undergone endovascular -/+ bypass surgery revascularization for moderate to severe claudication or ischemic rest pain.
  • Major cardiac events (myocardial infarctions, admission due to congestive heart failure and strokes, and death) [ Time Frame: month 1, 3, 6,9,12,or Early Termination ]
    To compare the effects of PRU-guided versus non-PRU-guided treatment on changes in the major cardiac events including fatal and non-fatal myocardial infarctions, admission for congestive heart failure, and strokes, and death over time life over time (pre-revascularization and 1, 3, 6, 9, 12 months post-revascularization, or early termination ) during 12 months of therapy in patients with Peripheral Artery Disease who have undergone endovascular -/+ bypass surgery revascularization for moderate to severe claudication or ischemic rest pain.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Post-operative Treatment of Diabetic Peripheral Arterial Disease Guided by Platelet Reactivity Unit
Official Title  ICMJE Post-operative Treatment of Diabetic Peripheral Arterial Disease Guided by Platelet Reactivity Unit
Brief Summary

To compare the effect of PRU(platelet (P2Y12) reaction units)-guided treatment on the change in

  1. time of initial leg pain and time of termination of exercise test by pain, evaluated on the graded stationary bicycle test,
  2. the lower limb perfusion by using MRI blood oxygenation-level dependent (BOLD) and dynamic contrast enhancement sequences and measures the extracellular volume fraction (ECV) as an indicator of fibrosis severity in calf muscles, from one to 52 weeks post-revascularization in patients with peripheral artery disease who have undergone endovascular revascularization -/+ bypass surgery for moderate to severe claudication or ischemic rest pain.
Detailed Description Patients will be randomly assigned to PRU-guided and non-PRU-guided group. In the non-PRU -target group, dual antiplatelet therapy with clopidogrel 75 mg and aspirin 100 mg daily will be continued for 6 months after the procedure for patient followed with single antiplatelet therapy with clopidogrel 75 mg daily throughout the follow-up period. In the PRU-target group, dual antiplatelet therapy will be the same protocol as in the non-PRU-target group for patients with PRU <234 seconds. However, for patients in the PRU-target group with PRU ≥234 seconds, rescue medicine will be added to keep PRU<234 seconds.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Artery Disease
Intervention  ICMJE
  • Other: platelet (P2Y12) reaction units
    VerifyNow P2Y12 assay point-of-care testing
  • Drug: ticagrelor
    Antiplatelet therapy approved for ACS. Antagonist of P2Y12 and inhibitor of adenosine diphosphate (ADP)-induced platelet aggregation.
    Other Name: Brilinta
  • Drug: Comparator
    dual antiplatelet therapy with clopidogrel 75 mg and aspirin 100 mg daily will be continued for 6 months after the procedure for patient followed with single antiplatelet therapy with clopidogrel 75 mg daily throughout the follow-up period.
    Other Names:
    • Aspirin
    • Clopidogrel
Study Arms  ICMJE
  • Experimental: PRU-guided
    dual antiplatelet therapy with clopidogrel 75 mg and aspirin 100 mg daily will be continued for 6 months after the procedure for patients with PRU <234 seconds and followed with single antiplatelet therapy with clopidogrel 75 mg daily throughout the follow-up period. For patients in the PRU-target group with PRU ≥234 seconds, rescue medicine (ticagrelor) will be added to keep PRU<234 seconds.
    Interventions:
    • Other: platelet (P2Y12) reaction units
    • Drug: ticagrelor
    • Drug: Comparator
  • Active Comparator: non PRU-guided
    dual antiplatelet therapy with clopidogrel 75 mg and aspirin 100 mg daily will be continued for 6 months after the procedure for patients with PRU <234 seconds and followed with single antiplatelet therapy with clopidogrel 75 mg daily throughout the follow-up period, regardless the levels of PRU.
    Interventions:
    • Other: platelet (P2Y12) reaction units
    • Drug: Comparator
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 3, 2016)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2019
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Written informed consent prior to any study specific procedures.
  2. Ambulatory male or female outpatients with diabetes mellitus aged 18-75 years of age or older at the time of the Screening Visit.
  3. Diagnosis of PAD confirmed by history and any one of the following observed in the index (intervention) leg at the Screening Visit:

    1. Resting ABI ≤0.90, or
    2. In patients with an ABI > 1.40 (non-compressible vessels) a resting GTI <0.70 can be used for inclusions.
  4. endovascular +/- bypass surgery for superficial femoral artery and/or popliteal and/or tibial arteries, that is planned to occur within 6 weeks after the screening visit. Patients receiving concomitant iliac artery endovascular procedures may be enrolled as long as their procedure also includes treating the distal SFA, popliteal or tibial arteries. The patient is randomised after revascularization procedure has been confirmed as technically successful.

Exclusion Criteria:

  1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
  2. Isolated iliac and/or common femoral arteries lesion.
  3. Participation in other clinical study with an investigational product within the last 3 months or any new clinical trial during the course of this study.
  4. Gangrene or ischemic ulcer of either lower extremity.
  5. PAD of a non-atherosclerotic nature.
  6. Chronic oral or parenteral anticoagulant therapy (greater than 7 days)
  7. Any health status that would interfere with exercise performance or prevent the patient from completion of MRI examinations.
  8. Any major lower limb amputation (minor toe amputations allowed if it does not interfere with ambulation).
  9. Myocardial infarction or stroke in the previous 3 months.
  10. Any concomitant disease process with a life expectancy of less than 1 year or which is sufficiently severe as to compromise the validity of test performance.
  11. Not fully understanding of information pertinent to study conduct or compliance to study procedures.
  12. Inability of the patient to comply with study procedures and/or followup (e.g., alcohol or drug abuse).
  13. A known bleeding diathesis, hemostatic or coagulation disorder, or systemic bleeding, whether resolved or ongoing.
  14. MRI examination is prohibited due to renal insufficiency or renal failure requiring dialysis. Any condition that can not receiving MRI examination, such as claustrophobia, previous abdominal aortic stent(strong artifact).
  15. History of previous intracranial bleed at any time, gastrointestinal bleed within the past 6 months, or major surgery within 30 days (if the surgical wound is judged to be associated with an increased risk of bleeding).
  16. Hypersensitivity to ticagrelor, aspirin or clopidogrel.
  17. Pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02762864
Other Study ID Numbers  ICMJE CMRPG2F0161
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chi-Hsiao Yeh, Chang Gung Memorial Hospital
Study Sponsor  ICMJE Chang Gung Memorial Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chi-Hsiao Yeh, MD pHD Chang Gung Memorial Hospital, Keeln\ung
PRS Account Chang Gung Memorial Hospital
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP