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Peripheral Artery Disease (PAD)Phase 2TI-PAD EVRNCT02227368

Walking Effect of Long Term Ticagrelor in Subjects With PAD Who Have Undergone EVR

A Phase 2 study testing Ticagrelor and Comparator in people with Peripheral Artery Disease (PAD), run by AstraZeneca at 10 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

To compare the effect of ticagrelor versus aspirin on the change in peak walking time, evaluated on the graded treadmill test, from one to 26 weeks post-revascularization in patients with peripheral artery disease who have undergone endovascular revascularization for moderate to severe claudication or ischemic rest… Read more about this study

Who is it for?
Ages 50 to 130 years
Conditions the study is for
Peripheral Artery Disease (PAD)
What is being tested?
Ticagrelor and Comparator
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
10 sitesUnited States
Study dates
20 Oct 2014to 23 May 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 130 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 29Show fewer
  • 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).

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Research Site

    Cleveland, Ohio, 44195

  • Research Site

    Daytona Beach, Florida, 32114

  • Research Site

    Jacksonville, Florida, 32216

  • Research Site

    McKinney, Texas, 75069

  • Research Site

    Munster, Indiana, 46321

  • Research Site

    New York, New York, 10001

  • Research Site

    Ocala, Florida, 34471

  • Research Site

    San Antonio, Texas, 78229

  • Research Site

    Sarasota, Florida, 34239

  • Research Site

    Yonkers, New York, 10701

Other trials in United States

About this study

Official title: 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

To compare the effect of ticagrelor versus aspirin on the change in peak walking time, evaluated on the graded treadmill test, from one to 26 weeks post-revascularization in patients with peripheral artery disease who have undergone endovascular revascularization for moderate to severe claudication or ischemic rest pain.

Read the detailed description

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.

Being tested
Ticagrelor, Comparator
Keywords
Myocardial Infarction, Peripheral Arterial disease, Mycardial Ischemia, Heart Diseases, Cardiovascular Diseases, Vascular Diseases, Altherosclerosis, Arteriosclerosis, Arterial Occlusive Diseases, Peripheral Vascular Diseases, Ticagrelor, Ticlopidine, Platelet Aggregation inhibitors, Hematologic Agents, Therapeutic Uses, Pharmacologic Actions, Purinegic P2Y Receptor Antagonists, Purinegic P2 Receptor Antagonists, Purinergic Antagonists, Purinergic Agents
Medical subject headings
Peripheral Arterial Disease, Myocardial Infarction, Heart Diseases, Cardiovascular Diseases, Vascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Peripheral Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TicagrelorDrug

    Also called Brilinta

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

  • ComparatorDrug

    Also called Aspirin

    Aspirin monotherapy anti-platelet treatment for PAD patients following EVR procedures

Study groups in NCT02227368
Study groupRoleWhat they receive
TicagrelorExperimental26 Weeks of ticagrelor 90mg twice a day plus aspirin placebo once daily
Receives: Drug: Ticagrelor
AspirinActive comparator26 Weeks of aspirin 100mg once daily plus ticagrelor placebo twice a day
Receives: Drug: Comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Log Transformed Peak Walking Time (PWT) at Week 26 or Early Termination (ET)

    Measured: 26 Weeks

Secondary outcomes (1)

  1. Change From Baseline in Log Transformed Claudication Onset Time (COT) at Week 26 or Early Termination (ET)

    Measured: 26 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2014 (estimated)
  2. Study start20 Oct 2014
  3. Primary completion23 May 2016
  4. Study completion23 May 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02227368
Sponsor's protocol ID
D5135L00003
Acronym
TI-PAD EVR
Status last verified
Jun 2017
First submitted
19 Aug 2014
Last updated
19 Jul 2017
Data monitoring committee
No

Publications

  • Rogers RK, Hiatt WR, Patel MR, Shishehbor MH, White R, Khan ND, Bhalla NP, Jones WS, Low Wang CC. Ticagrelor in Peripheral Artery Disease Endovascular Revascularization (TI-PAD): Challenges in clinical trial execution. Vasc Med. 2018 Dec;23(6):513-522. doi: 10.1177/1358863X18760996. Epub 2018 Apr 9.

    PubMed 29629845

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ticagrelor and Comparator in people with Peripheral Artery Disease (PAD), run by AstraZeneca at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Log Transformed Peak Walking Time (PWT) at Week 26 or Early Termination (ET) (time frame: 26 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02227368, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2017.

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