Phase 3 N=70 Randomized Triple-blind Treatment

Comparative Efficacy of Ticagrelor Versus Aspirin on Blood Viscosity in Peripheral Artery Disease Patients With Type 2 Diabetes

Peripheral Artery Disease · Type 2 Diabetes

Bottom Line

View on ClinicalTrials.gov: NCT02325466 ↗

Enrolled (actual)

Serious AEs

0.5%

Results posted

Mar 2022

Primary outcome: Primary: Mean Change in Low Shear Blood Viscosity — 1.045; -1.793; -1.759 5 s^-1 cPs

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Aspirin (Drug); Ticagrelor (Drug); Aspirin Placebo (Drug); Ticagrelor Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Icahn School of Medicine at Mount Sinai
Primary completion: May 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change in Low Shear Blood Viscosity	1.045; -1.793; -1.759	—
PRIMARY Mean Change in High Shear Blood Viscosity	0.165; -0.228; -0.231	—
SECONDARY Mean Change in Peripheral Arterial Blood Flow	0.038; 0.021; 0.095; 0.015; 0.032; 0.075	—
SECONDARY Mean Change in Microvascular Blood Flow Composite Score	-4.10; 13.64; -5.23; -5.60; 24.76; -4.29	—

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02325466). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.