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

NCT02230527 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 14-799
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Absolute Change in TcPO2 From Baseline to Month 6

  The primary endpoint is the absolute change in TcPO2 from baseline to month 6 compared between treatment groups.

  6 months

Study Arms (2)

Clopidogrel

ACTIVE COMPARATOR

Clopidogrel 75mg by mouth daily

Drug: Clopidogrel

Ticagrelor

EXPERIMENTAL

Ticagrelor 90mg by mouth twice daily

Drug: Ticagrelor

Interventions

Ticagrelor DRUG

90mg twice a day by mouth

Also known as: Brilinta, Brilique, Possia

Ticagrelor

Clopidogrel DRUG

75mg once a day by mouth

Also known as: Plavix

Clopidogrel

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Willingness to sign informed consent
• Ability to return for follow up visits
• 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.

You may not qualify if:

• Patients will be ineligible for this study if they meet any one of the following criteria:
• Intolerance to thienopyridines
• Hypersensitivity to ticagrelor or any component of the product.
• Concomitant use of oral anticoagulation with vitamin K antagonist, factor Xa inhibitor, or direct thrombin inhibitor
• History of intracranial hemorrhage
• History of severe hepatic impairment defined by baseline transaminase greater than or equal to 3x ULN or any elevation in bilirubin
• Active bleeding
• Allergy to aspirin
• Baseline TcPO2 \< 10 mmHg post angiography
• Resting, pre- procedure heart rate \<50 beats-per-minute without a permanent pacemaker and not on an atrioventricular nodal blocking agent
• Severe COPD on home oxygen therapy -

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Ticagrelor; Clopidogrel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Joseph Campbell, MD
• Organization: Cleveland Clinic

campbej10@ccf.org

216-444-9836

Study Officials

• Joseph Campbell, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 26, 2014
• First Posted: September 3, 2014
• Study Start: October 1, 2014
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: July 7, 2021
• Results First Posted: July 7, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)