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

• Status: Unknown status
• Trial end date: 2019-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chang Gung Memorial Hospital
• Treatments: Aspirin; Clopidogrel; Ticagrelor; Ticlopidine

Criteria

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