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Establishing the Microcirculatory Effects of Ticagrelor on Tissue Perfusion in Critical Limb Ischemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02230527
Recruitment Status : Recruiting
First Posted : September 3, 2014
Last Update Posted : November 15, 2019
Information provided by (Responsible Party):
Joseph Campbell, The Cleveland Clinic

Brief Summary:
This is a single center, prospective, randomized, unblinded, open-label, active controlled pilot study to evaluate the efficacy and safety of ticagrelor plus aspirin versus clopidogrel plus aspirin in patients with Rutherford Stage IV to VI PAD that have undergone a percutaneous transluminal angioplasty (PTA) of the lower extremities in the past 2 weeks.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Drug: Ticagrelor Drug: Clopidogrel Phase 2 Phase 3

Detailed Description:

Enrollment into the study will require severe symptomatic CLI without wounds (Rutherford Stage IV) or CLI with concomitant vascular insufficiency wounds (Rutherford Stage V-VI PAD).

Potential participants will be identified and screened prior to discharge or at the time of the first out-patient visit (within 2 weeks after discharge) after a percutaneous lower extremity arterial angiography with arterial intervention (stent or balloon angioplasty) for the presence of lower extremity vascular insufficiency. Participants will be classified as Rutherford Class IV - VI (with or without ulcerations). A total of 60 patients will be randomized into 2 treatment groups in a 1:1 ratio (ticagrelor to clopidogrel). Patients are placed on clopidogrel after their arterial intervention per standard of care. They will remain on clopidogrel up to the time that randomization occurs. For patients that are randomized to ticagrelor, the clopidogrel will be stopped.

Patients will be randomized to either ticagrelor 90mg by mouth twice daily or clopidogrel 75mg by mouth daily.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Establishing the Microcirculatory Effects of Ticagrelor on Tissue Perfusion in Critical Limb Ischemia
Actual Study Start Date : October 2014
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Clopidogrel
Clopidogrel 75mg by mouth daily
Drug: Clopidogrel
75mg once a day by mouth
Other Name: Plavix

Experimental: Ticagrelor
Ticagrelor 90mg by mouth twice daily
Drug: Ticagrelor
90mg twice a day by mouth
Other Names:
  • Brilinta
  • Brilique
  • Possia

Primary Outcome Measures :
  1. The primary endpoint is the absolute change in TcPO2 from baseline to month 6 compared between treatment groups. [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Adults age 18-100 years with Rutherford Classification Stage IV through VI PAD with a recent percutaneous lower extremity arterial angiography with arterial intervention in the past 2 weeks
  2. Willingness to sign informed consent
  3. Ability to return for follow up visits
  4. A female patient of childbearing potential who is sexually active must agree to use adequate contraception from screening until 30 days after receiving the last dose of study drug. Women not of childbearing potential are defined as those who have surgically sterilized (hysterectomy, bilateral oophorectomy, or tubal ligation) or who are post menopausal (defined as at least 2 years since last regular menses). The female patient should not be lactating and must have a negative pregnancy test at screening.

Exclusion Criteria:

Patients will be ineligible for this study if they meet any one of the following criteria:

  1. Intolerance to thienopyridines
  2. Hypersensitivity to ticagrelor or any component of the product.
  3. Concomitant use of oral anticoagulation with vitamin K antagonist, factor Xa inhibitor, or direct thrombin inhibitor
  4. History of intracranial hemorrhage
  5. History of severe hepatic impairment defined by baseline transaminase greater than or equal to 3x ULN or any elevation in bilirubin
  6. Active bleeding
  7. Allergy to aspirin
  8. Baseline TcPO2 < 10 mmHg post angiography
  9. Resting, pre- procedure heart rate <50 beats-per-minute without a permanent pacemaker and not on an atrioventricular nodal blocking agent
  10. Severe COPD on home oxygen therapy -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02230527

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Contact: Joseph Campbell, MD 216 444-9836

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United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Joseph Campbell, MD    216-444-9836   
Principal Investigator: Joseph Campbell, MD         
Sub-Investigator: David Hardy, MD         
Sponsors and Collaborators
The Cleveland Clinic
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Principal Investigator: Joseph Campbell, MD The Cleveland Clinic

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Responsible Party: Joseph Campbell, Principal Investigator, The Cleveland Clinic Identifier: NCT02230527    
Other Study ID Numbers: 14-799
First Posted: September 3, 2014    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Pathologic Processes
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs