Comparative Efficacy of Ticagrelor Versus Aspirin on Blood Viscosity in Peripheral Artery Disease Patients With Type 2 Diabetes
Condition: Peripheral Artery Disease; Type 2 Diabetes
MeSH terms: Peripheral Arterial Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Aspirin; Ticagrelor; Aspirin Placebo; Ticagrelor Placebo
Intervention description: Aspirin 81mg; ticagrelor 90 mg
Intervention MeSH terms: Aspirin; Ticagrelor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Peripheral Artery Disease; Type 2 Diabetes; Blood Viscosity; Ticagrelor; Aspirin

Summary:

      The hypothesis being that both aspirin-ticagrelor and ticagrelor monotherapy will be superior
      to aspirin monotherapy in the reduction of whole blood viscosity at the end of each 4 week
      treatment period. Study participants will be randomized into 3 groups, and each group will
      receive each of 3 treatments in the cross-over study. At the end of each individual 4 week
      treatment period the investigators will determine whether there are differences in low and
      high shear rate dependent viscosity and investigate the effect of the treatment on peripheral
      arterial blood flow using pulse volume recordings, ankle brachial index and toe pressures.
      Subjects will be eligible if they have ankle-brachial index less than or equal to 0.85, or if
      a patient's blood vessels are calcified, patients will have toe-brachial index less than or
      equal to 0.6 performed using continuous-wave Doppler.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female or male aged ≥ 35 years

          -  Type 2 diabetes mellitus

          -  Symptomatic PAD

          -  Ankle-brachial index ≤ 0.85 or calcified blood vessels with toe-brachial index ≤ 0.6
             and/or abnormal post-exercise ankle-brachial index

          -  Prior surgical or percutaneous intervention of the peripheral arteries ≥12 months
             previously with a residual stenoses of ≥50% in a non-dilated artery.

        Exclusion Criteria:

          -  Subject is pregnant or breast-feeding

          -  Planned revascularization or amputation

          -  Known bleeding disorder

          -  History of intracranial hemorrhag3

          -  Considered at risk of hemorrhagic events

          -  Hypersensitivity or allergic reactions to aspirin

          -  Concomitant use of anticoagulants such as warfarin, dabigatran, factor Xa inhibitors
             or antiplatelet drugs such as clopidogrel, dipyridamole and sulfapyridine

          -  Subject has a condition or circumstance which would prevent them from adhering to
             treatment regimens

          -  Subject has active infection

          -  Subject has an anemia

          -  Subject has given blood or received a blood transfusion at any point during the study

          -  Subject has polycythemia vera or any hyperviscosity syndrome

          -  Subjects with Waldenstrom's macroglobulinemia who have an increased risk of
             hyperviscosity syndrome

          -  Subject has history of severe liver disease, obstructive liver disease such as primary
             biliary cirrhosis or end-stage renal disease (eGFR <30 mL/min/m2)

          -  Family members or employees of the investigator or study centers involved in the study

          -  Subject has poor diabetes or hypertension control (systolic blood pressure ≥ 180 mmHg
             or diastolic blood pressure ≥ 100 mmHg)