Comparative Efficacy of Ticagrelor Versus Aspirin on Blood Viscosity in Peripheral Artery Disease Patients With Type 2 Diabetes
1 other identifier
interventional
70
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2015
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2014
CompletedFirst Posted
Study publicly available on registry
December 25, 2014
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 4, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 4, 2018
CompletedResults Posted
Study results publicly available
March 21, 2022
CompletedMarch 21, 2022
March 1, 2022
3.1 years
December 19, 2014
May 6, 2019
March 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mean Change in Low Shear Blood Viscosity
Compare the effect of aspirin-ticagrelor and ticagrelor monotherapy with aspirin on blood viscosity from week 16 to baseline
baseline, week 16
Mean Change in High Shear Blood Viscosity
Compare the effect of aspirin-ticagrelor and ticagrelor monotherapy with aspirin on blood viscosity at week 16 to baseline
baseline and week 16
Secondary Outcomes (2)
Mean Change in Peripheral Arterial Blood Flow
baseline and week 16
Mean Change in Microvascular Blood Flow Composite Score
baseline and week 16
Study Arms (3)
Aspirin/Ticagrelor placebo
PLACEBO COMPARATORaspirin 81 mg daily and ticagrelor placebo twice daily
Aspirin/Ticagrelor
ACTIVE COMPARATORaspirin 81 mg daily and ticagrelor 90 mg twice daily
Aspirin Placebo/Ticagrelor
ACTIVE COMPARATORaspirin placebo daily and ticagrelor 90 mg twice daily
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Related Publications (1)
Rosenson RS, Chen Q, Najera SD, Krishnan P, Lee ML, Cho DJ. Ticagrelor improves blood viscosity-dependent microcirculatory flow in patients with lower extremity arterial disease: the Hema-kinesis clinical trial. Cardiovasc Diabetol. 2019 Jun 7;18(1):77. doi: 10.1186/s12933-019-0882-5.
PMID: 31174526DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Robert S. Rosenson
- Organization
- Icahn School of Medicine at Mount Sinai
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Rosenson, MD
Icahn School of Medicine at Mount Sinai
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Medicine, Cardiology
Study Record Dates
First Submitted
December 19, 2014
First Posted
December 25, 2014
Study Start
April 1, 2015
Primary Completion
May 4, 2018
Study Completion
May 4, 2018
Last Updated
March 21, 2022
Results First Posted
March 21, 2022
Record last verified: 2022-03