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

NCT02762864 | Unknown DMC

• 1 other identifier: CMRPG2F0161
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare the effect of PRU(platelet (P2Y12) reaction units)-guided treatment on the change in

1. 1.time of initial leg pain and time of termination of exercise test by pain, evaluated on the graded stationary bicycle test,
2. 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.

Conditions

Peripheral Artery Disease

Keywords

aspirin; ticagrelor; clopidogrel

Outcome Measures

Primary Outcomes (4)

• Peak exercise time

  To compare the effects of PRU-guided versus non-PRU-guided treatment on changes in the leg peak exercise time over time (pre-revascularization and 12 months post-revascularization, or early termination ) during 12 months of therapy in patients with Peripheral Artery Disease who have undergone endovascular -/+ bypass surgery revascularization for moderate to severe claudication or ischemic rest pain.

  month 0,12,or Early Termination

• Limb hemodynamics (Ankle Brachial Index or Great Toe Index)

  To compare the effects of PRU-guided versus non-PRU-guided treatment on changes in the Limb hemodynamics (Ankle Brachial Index or Great Toe Index) over time (pre-revascularization and at 1, 6, and 12 months post-revascularization) during 12 months of therapy in patients with Peripheral Artery Disease who have undergone endovascular -/+ bypass surgery revascularization for moderate to severe claudication or ischemic rest pain.

  month 0,1,6,12,or Early Termination

• leg pain MRI perfusion measures

  To compare the effects of PRU-guided versus non-PRU-guided treatment on changes in the lower leg muscle GOLD perfusion measure over time (pre-revascularization, 4, and 12 months post-revascularization, or early termination ) during 12 months of therapy in patients with Peripheral Artery Disease who have undergone endovascular -/+ bypass surgery revascularization for moderate to severe claudication or ischemic rest pain.

  month 0,4,12,or Early Termination

• Quality of life measures

  To compare the effects of PRU-guided versus non-PRU-guided treatment on changes in the quality of life over time (pre-revascularization and 12 months post-revascularization, or early termination ) during 12 months of therapy in patients with Peripheral Artery Disease who have undergone endovascular -/+ bypass surgery revascularization for moderate to severe claudication or ischemic rest pain.

  month 0,12,or Early Termination

Secondary Outcomes (4)

• Major lower leg events (above the ankle amputations, revascularization procedures)

  month1, 3, 6,9,12,or Early Termination

• Major bleeding events

  month1, 3, 6,9,12,or Early Termination

• leg pain (claudication) onset time

  month 0,12,or Early Termination

• Major cardiac events (myocardial infarctions, admission due to congestive heart failure and strokes, and death)

  month 1, 3, 6,9,12,or Early Termination

Study Arms (2)

PRU-guided

EXPERIMENTAL

dual antiplatelet therapy with clopidogrel 75 mg and aspirin 100 mg daily will be continued for 6 months after the procedure for patients with PRU \<234 seconds and followed with single antiplatelet therapy with clopidogrel 75 mg daily throughout the follow-up period. For patients in the PRU-target group with PRU ≥234 seconds, rescue medicine (ticagrelor) will be added to keep PRU\<234 seconds.

Other: platelet (P2Y12) reaction units; Drug: ticagrelor; Drug: Comparator

non PRU-guided

ACTIVE COMPARATOR

dual antiplatelet therapy with clopidogrel 75 mg and aspirin 100 mg daily will be continued for 6 months after the procedure for patients with PRU \<234 seconds and followed with single antiplatelet therapy with clopidogrel 75 mg daily throughout the follow-up period, regardless the levels of PRU.

Other: platelet (P2Y12) reaction units; Drug: Comparator

Interventions

platelet (P2Y12) reaction units OTHER

VerifyNow P2Y12 assay point-of-care testing

PRU-guided; non PRU-guided

ticagrelor DRUG

Antiplatelet therapy approved for ACS. Antagonist of P2Y12 and inhibitor of adenosine diphosphate (ADP)-induced platelet aggregation.

Also known as: Brilinta

PRU-guided

Comparator DRUG

dual antiplatelet therapy with clopidogrel 75 mg and aspirin 100 mg daily will be continued for 6 months after the procedure for patient followed with single antiplatelet therapy with clopidogrel 75 mg daily throughout the follow-up period.

Also known as: Aspirin, Clopidogrel

PRU-guided; non PRU-guided

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent prior to any study specific procedures.
• Ambulatory male or female outpatients with diabetes mellitus aged 18-75 years of age or older at the time of the Screening Visit.
• Diagnosis of PAD confirmed by history and any one of the following observed in the index (intervention) leg at the Screening Visit:
• Resting ABI ≤0.90, or
• 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.

You may not qualify if:

• Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
• Isolated iliac and/or common femoral arteries lesion.
• 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.
• Gangrene or ischemic ulcer of either lower extremity.
• PAD of a non-atherosclerotic nature.
• Chronic oral or parenteral anticoagulant therapy (greater than 7 days)
• Any health status that would interfere with exercise performance or prevent the patient from completion of MRI examinations.
• Any major lower limb amputation (minor toe amputations allowed if it does not interfere with ambulation).
• Myocardial infarction or stroke in the previous 3 months.
• 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.
• Not fully understanding of information pertinent to study conduct or compliance to study procedures.
• Inability of the patient to comply with study procedures and/or followup (e.g., alcohol or drug abuse).
• A known bleeding diathesis, hemostatic or coagulation disorder, or systemic bleeding, whether resolved or ongoing.
• 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).
• 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).

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Platelet Count; Receptors, Purinergic P2Y12; Ticagrelor; Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Platelet Function Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Receptors, Purinergic P2Y; Receptors, Purinergic P2; Receptors, Purinergic; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Neurotransmitter; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Chi-Hsiao Yeh, MD pHD

  Chang Gung Memorial Hospital, Keeln\ung

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: May 5, 2016
• Study Start: May 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: May 5, 2016

Record last verified: 2016-05