- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02227368
Walking Effect of Long Term Ticagrelor in Subjects With PAD Who Have Undergone EVR (TI-PAD EVR)
A Phase II Multicentre, Randomised, Double-Blind, Controlled, Parallel-Group Study to Evaluate the Walking Time Effect of Long-Term Ticagrelor in Comparison to Long-Term Aspirin Administration in Ambulatory Patients With Peripheral Artery Disease Undergoing Endovascular Revascularization - The Ticagrelor in Peripheral Artery Disease Endovascular Revascularization Study TI-PAD I EVR
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Florida
-
Daytona Beach, Florida, United States, 32114
- Research Site
-
Jacksonville, Florida, United States, 32216
- Research Site
-
Ocala, Florida, United States, 34471
- Research Site
-
Sarasota, Florida, United States, 34239
- Research Site
-
-
Indiana
-
Munster, Indiana, United States, 46321
- Research Site
-
-
New York
-
New York, New York, United States, 10001
- Research Site
-
Yonkers, New York, United States, 10701
- Research Site
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Research Site
-
-
Texas
-
McKinney, Texas, United States, 75069
- Research Site
-
San Antonio, Texas, United States, 78229
- Research Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- Written informed consent prior to any study specific procedures.
- Ambulatory male or female outpatients aged 50 years of age or older at the time of the Screening Visit.
- EVR, below the inguinal ligament that includes the distal SFA and/or popliteal and/or tibial arteries, that is planned to occur within 5 weeks after the Screening Visit, as determined and clearly documented by the Principal Investigator or physician Sub-Investigator (MD/DO). Patients undergoing a proximal revascularization may be enrolled as long as their procedure also includes treating the distal SFA, popliteal or tibial arteries. The EVR must be confirmed as technically successful (a completed procedure where haemostasis has been achieved) before the patient is randomised.
- Normal inflow into the lower extremity as determined by the Principal Investigator or physician Sub-Investigator (MD/DO). Adequacy of inflow can be assessed by hemodynamic measures, angiography or other imaging modalities obtained during Screening or recorded in the medical records up to 30 days prior to the Screening Visit or as defined by imaging at the time of the procedure. A patient with inadequate inflow at the time of Screening can still be enrolled if the inflow is addressed and resolved by the planned revascularization procedure.
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
- In patients with an ABI > 1.40 (non-compressible vessels) a resting GTI <0.70 can be used for inclusions.
- Patient has been advised of the beneficial effects of smoking cessation and exercise therapy but is not in the process of changing their smoking status or exercise at the time of the Screening Visit.
Exclusion Criteria
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- Revascularisation planned only to treat proximal (inflow) disease in the iliac and/or common femoral arteries.
- Previous randomisation in the present study.
- Participation in another 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.
- Clinical necessity to use dual antiplatelet therapy within 7 days prior to randomisation, or single anti-platelet therapy (ticlopidine, prasugrel, vorapaxar, ticagrelor or dipyridamole) other than clopidogrel or aspirin. Clopidogrel or aspirin can be taken up to and including the time that the loading dose is being given.
Clinical necessity to use the following restricted concomitant medications within 4 weeks prior to randomisation. Patients taking any of these medications at the Screening Visit may be considered for randomisation after a 4 week washout period from the medication.
- Pentoxifylline or cilostazol for relief of claudication symptoms
- Chronic oral or parenteral anticoagulant therapy (greater than 7 days)
- Strong inhibitors of CYP3A enzymes (Section 5.6.9.1)
- Strong inducers of CYP3A enzymes (Section 5.6.9.2)
- Simvastatin or lovastatin at daily doses over 40 mg
- Any disease process (e.g. angina, cardiac abnormality, congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), respiratory disease, obesity, stroke, severe neuropathy of the foot, symptomatic musculoskeletal disease of the lower extremity), other than PAD, that would interfere with exercise performance during the ETT or prevent the patient from reaching their claudication-limited PWT as the primary endpoint of the study.
- Coronary, aortic surgery, angioplasty, lumbar sympathectomy or lower extremity surgery that impacts the ability to walk on a treadmill within the past 3 months prior to EVR. Revascularization of the non-index lower extremity within the past 4 weeks prior to EVR.
- Any major lower limb amputation due to PAD anticipated within the next 3 months or prior major amputation due to PAD (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.
- Dementia likely to jeopardise understanding of information pertinent to study conduct or compliance to study procedures.
- Concern for the inability of the patient to comply with study procedures and/or followup (e.g., alcohol or drug abuse).
- Resting systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥95 mmHg at the Screening Visit, in spite of antihypertensive treatments allowed by the protocol.
- A known bleeding diathesis, haemostatic or coagulation disorder, or systemic bleeding, whether resolved or ongoing.
- Known severe liver disease (e.g., ascites and or clinical signs of coagulopathy).
- Renal failure requiring dialysis.
- 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).
- History of thrombocytopenia or neutropenia.
- Hypersensitivity to ticagrelor, aspirin or lactose.
- Initiation of antidiabetic, antihypertensive, lipid-lowering and beta-blocking drugs within 1 month prior to the Screening Visit.
- Pregnancy, lactation, fertility without protection against pregnancy (for women of childbearing potential; a urine or serum pregnancy test will be performed at the Screening Visit).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ticagrelor
26 Weeks of ticagrelor 90mg twice a day plus aspirin placebo once daily
|
Antiplatelet therapy approved for ACS.
Antagonist of P2Y12 and inhibitor of adenosine diphosphate (ADP)-induced platelet aggregation.
Other Names:
|
Active Comparator: Aspirin
26 Weeks of aspirin 100mg once daily plus ticagrelor placebo twice a day
|
Aspirin monotherapy anti-platelet treatment for PAD patients following EVR procedures
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change From Baseline in Log Transformed Peak Walking Time (PWT) at Week 26 or Early Termination (ET)
Time Frame: 26 Weeks
|
26 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change From Baseline in Log Transformed Claudication Onset Time (COT) at Week 26 or Early Termination (ET)
Time Frame: 26 Weeks
|
26 Weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: William Hiatt, MD, Colorado Prevention Center Clinical Research
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Ticagrelor
- Vascular Diseases
- Cardiovascular Diseases
- Myocardial Infarction
- Physiological Effects of Drugs
- Pharmacologic Actions
- Arteriosclerosis
- Heart Diseases
- Therapeutic Uses
- Neurotransmitter Agents
- Peripheral Vascular Diseases
- Arterial Occlusive Diseases
- Hematologic Agents
- Fibrinolytic Agents
- Peripheral Arterial disease
- Mycardial Ischemia
- Altherosclerosis
- Ticlopidine
- Platelet Aggregation inhibitors
- Purinegic P2Y Receptor Antagonists
- Purinegic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Molecular Mechanisms of Pharmacological Actions
- Crardiovascular Agents
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Atherosclerosis
- Peripheral Vascular Diseases
- Peripheral Arterial Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Platelet Aggregation Inhibitors
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Ticagrelor
Other Study ID Numbers
- D5135L00003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Peripheral Artery Disease (PAD)
-
Fangge DengRecruitingPeripheral Artery Disease (PAD)China
-
Fundacion para la Formacion e Investigacion Sanitarias...Not yet recruiting
-
Rontis Hellas SAPharmassist LtdActive, not recruitingPeripheral Artery Disease (PAD)Greece
-
Michael Lichtenberg, MDCompletedPeripheral Artery Disease (PAD)Germany
-
Dartmouth-Hitchcock Medical CenterSociety for Vascular SurgeryCompletedPeripheral Artery Disease (PAD)United States
-
Janssen Scientific Affairs, LLCHCA Research Institute, LLCRecruitingCoronary Artery Disease (CAD) | Peripheral Artery Disease (PAD)United States
-
Milton S. Hershey Medical CenterRecruiting
-
Philips Clinical & Medical Affairs GlobalNAMSANot yet recruitingPeripheral Artery Disease | PAD | Peripheral Artery Stenosis | Peripheral Artery Calcification
-
Cordis CorporationMassachusetts General Hospital; Prairie Education and Research CooperativeCompletedCardiovascular Diseases | Peripheral Vascular Disease | Peripheral Artery Disease | Vascular Disease | PADUnited States, Belgium
-
Emory UniversityNational Heart, Lung, and Blood Institute (NHLBI)RecruitingPeripheral Artery Disease (PAD)United States
Clinical Trials on Ticagrelor
-
Collegium Medicum w BydgoszczyCompleted
-
Federico II UniversityAdvicePharma GroupCompletedMyocardial Infarction | Coronary Artery Disease | Acute Coronary Syndrome | STEMI | NSTEMIItaly
-
University of FloridaCompleted
-
AstraZenecaParexelCompletedSickle Cell DiseaseGermany
-
University of FloridaAstraZenecaCompleted
-
University of FloridaThe Medicines CompanyCompletedCoronary Artery DiseaseUnited States
-
Centro Hospitalario La ConcepcionRecruiting
-
Sheba Medical CenterCompletedST Elevation Myocardial Infarction | Acute Coronary SyndromesIsrael
-
David AntoniucciAstraZeneca; A.R. CARD Onlus FoundationCompletedAcute Coronary Syndrome | Adverse Reaction to Antiplatelet AgentItaly, Greece
-
Weill Medical College of Cornell UniversityCanadian Institutes of Health Research (CIHR)Not yet recruitingChronic Coronary DiseaseUnited States, Austria, Canada, Germany, Sweden