| Trial ID: | L1794 |
| Source ID: | NCT02325466
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| Associated Drug: |
Aspirin
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| Title: |
Comparative Efficacy of Ticagrelor Versus Aspirin on Blood Viscosity in Peripheral Artery Disease Patients With Type 2 Diabetes
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT02325466/results
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| Conditions: |
Peripheral Artery Disease|Type 2 Diabetes
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| Interventions: |
DRUG: Aspirin|DRUG: Ticagrelor|DRUG: Aspirin Placebo|DRUG: Ticagrelor Placebo
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| Outcome Measures: |
Primary: 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: Mean Change in Peripheral Arterial Blood Flow, Measure of treatment effect using pulse volume recordings of the ankle, great toe and brachial artery to calculate the ankle brachial index (ABI) and toe brachial index (TBI) at week 16 compared to baseline. ABI and TBI are taken in order to determine the existence and severity of peripheral arterial disease. ABI - The normal range for the ankle-brachial index is between 0.90 and 1.30. ABI \<0.90 is abnormal: 0.41 to 0.90 indicates mild to moderate peripheral artery disease; 0.40 and lower indicates severe disease. The lower the index, the higher the chances of leg pain while exercising or limb-threatening low blood flow. TBI ≥ 0.7 is normal, TBI \< 0.7 is abnormal., baseline and week 16|Mean Change in Microvascular Blood Flow Composite Score, Measure of treatment effect using pulse volume recordings of the ankle, great toe and brachial artery to calculate the ankle brachial index and toe pressures composite score at week 16 from baseline. Composite score obtained by adding all the measurements and averaged. The score was tested by the Laser Doppler Flowmetry (LDF). Minimum score is 0 which mean no blood flow detected and there is no maximum value of the score, and higher score mean better blood flow., baseline and week 16
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| Sponsor/Collaborators: |
Sponsor: Icahn School of Medicine at Mount Sinai
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE3
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| Enrollment: |
70
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
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| Start Date: |
2015-04
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| Completion Date: |
2018-05-04
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| Results First Posted: |
2022-03-21
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| Last Update Posted: |
2022-03-21
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| Locations: |
Icahn School of Medicine at Mount Sinai, New York, New York, 10029, United States
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| URL: |
https://clinicaltrials.gov/show/NCT02325466
|
