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Ticagrelor vs Clopidogrel Effect on MFR in CAD Population (PATH)

Primary Purpose

Coronary Artery Disease

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Ticagrelor

Clopidogrel

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring myocardial blood flow, myocardial perfusion imaging, myocardial blood flow reserve, positron emission tomography, adenosine, ticagrelor, clopidogrel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18 years old
Stable coronary artery disease on stable medical treatment.
BMI equal to or less than 30 kg/m2
No clinically significant abnormalities in baseline laboratory work
No clinically significant arrhythmias on baseline 12-lead electrocardiogram
Female subjects must be post-menopausal, surgically sterilized or have negative urine beta human chorionic gonadotropin pregnancy test at initial screening and maintain effective contraceptive methods throughout the trial and for 7 days following the end of dosing treatment.

Exclusion Criteria:

Any contraindication against the use of clopidogrel, ticagrelor and/or ASA.
Oral anticoagulation therapy.
History of intracranial bleeding.
Recent or active pathological bleeding, such as peptic ulcer.
Moderate or severe hepatic impairment.
History or risk of bradycardia.
Known second- or third-degree AV block without pacemaker
Dyspnea (NYHA III/IV), wheezing asthma or COPD.
Coronary artery bypass graft (CABG) surgery within 90 days prior to screening or at any time after consent.
Percutaneous coronary intervention (PCI) within 90 days prior to screening or at any time following consent.
Acute myocardial infarction or acute coronary syndrome within 60 days prior to screening or at any time following consent.
Any scheduled surgery during the trial period, including dental.
Concomitant therapy with strong cytochrome CYP 3A inhibitor or inducer.
Recent use of dipyridamole, dipyridamole-containing medications (e.g. Aggrenox)
Known hypersensitivity to the investigational drug or any of its components.
Known hypersensitivity to adenosine.
Lactose intolerance
Breastfeeding or pregnancy.
Claustrophobia or inability to lie still in a supine position
Unwillingness to provide informed consent

Sites / Locations

University of Ottawa Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

stable CAD management

CAD comparison group

Arm Description

Experimental: Ticagrelor (BrilintaTM) 90 mg tablet by mouth twice a day

Active comparator: clopidogrel 75 mg plus placebo tablet by mouth twice a day.

Outcomes

Primary Outcome Measures

Differences in rest MBF, stress MBF and MBFR between ticagrelor and clopidogrel treated patients as measured by PET

Blinded study drug will be administered for 10 days after which the subject will undergo MPI imaging to measure MBF. The crossover to the other study arm will occur and the study procedure repeated. Actual study drug effect will not be known until the study has completed and the treatment unblinded.

Secondary Outcome Measures

The effect of ticagrelor on rest MBF, stress MBF and MBFR will be compared in the normal versus abnormal segments on a segmental and patient basis in the ticagrelor treated subjects

Blinded study drug will be administered for 10 days after which the subject will undergo MPI imaging to measure rest/stress MBF and myocardial blood flow reserve. The crossover to the other study arm will occur and the study procedure repeated. Actual study drug effecting flow will not be known until the study has completed and the treatment unblinded.

Full Information

NCT ID

NCT01894789

First Posted

February 27, 2013

Last Updated

April 21, 2017

Sponsor

Ottawa Heart Institute Research Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01894789

Brief Title

Ticagrelor vs Clopidogrel Effect on MFR in CAD Population

Acronym

PATH

Official Title

ComPArison of the Effect of Ticagrelor Versus Clopidogrel on Myocardial Blood Flow (MBF) and Reserve (MBFR) Measured With Positron Emission TomograpHy (PET) in Patients With Coronary Artery Disease (CAD): The PATH Study

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

March 2013 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ottawa Heart Institute Research Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Ticagrelor is one of 3 anti-platelet medications used in patients with acute coronary syndrome (ACS) to prevent further clot formation and further ischemic damage to myocardial tissue. Overall benefits of one drug over the other is neutral in this generally unstable population. In pre-clinical trials, ticagrelor showed secondary effects, involving the release of adenosine to heart muscle where the demand for blood was increased due to a stress condition. Blood flow was increased, potentially preventing potential damage. This study will compare ticagrelor, currently only approved for use in ACS patients, against clopidogrel by measuring the myocardial blood flow(MBF) during stress to validate this phenomenon. The effect on blood flow will be measurable by using two specific doses of adenosine as the pharmacologic stress and correlating with measurements of blood flow using positron emission tomography (PET) nuclear imaging. This study hypothesizes that the increase in MBF during intermediate dose adenosine infusion will be greater in ticagrelor treated subjects compared to clopidogrel treated subjects

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

myocardial blood flow, myocardial perfusion imaging, myocardial blood flow reserve, positron emission tomography, adenosine, ticagrelor, clopidogrel

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

stable CAD management

Arm Type

Experimental

Arm Description

Experimental: Ticagrelor (BrilintaTM) 90 mg tablet by mouth twice a day

Arm Title

CAD comparison group

Arm Type

Active Comparator

Arm Description

Active comparator: clopidogrel 75 mg plus placebo tablet by mouth twice a day.

Intervention Type

Drug

Intervention Name(s)

Ticagrelor

Other Intervention Name(s)

BrilintaTM

Intervention Description

Blinded administration of ticagrelor for 10 days

Intervention Type

Drug

Intervention Name(s)

Clopidogrel

Intervention Description

Blinded administration of clopidogrel and placebo for 10 days

Primary Outcome Measure Information:

Title

Differences in rest MBF, stress MBF and MBFR between ticagrelor and clopidogrel treated patients as measured by PET

Description

Time Frame

q 2 weeks blood flow measurements

Secondary Outcome Measure Information:

Title

The effect of ticagrelor on rest MBF, stress MBF and MBFR will be compared in the normal versus abnormal segments on a segmental and patient basis in the ticagrelor treated subjects

Description

Time Frame

q 2 weeks blood flow measurements

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 years old Stable coronary artery disease on stable medical treatment. BMI equal to or less than 30 kg/m2 No clinically significant abnormalities in baseline laboratory work No clinically significant arrhythmias on baseline 12-lead electrocardiogram Female subjects must be post-menopausal, surgically sterilized or have negative urine beta human chorionic gonadotropin pregnancy test at initial screening and maintain effective contraceptive methods throughout the trial and for 7 days following the end of dosing treatment. Exclusion Criteria: Any contraindication against the use of clopidogrel, ticagrelor and/or ASA. Oral anticoagulation therapy. History of intracranial bleeding. Recent or active pathological bleeding, such as peptic ulcer. Moderate or severe hepatic impairment. History or risk of bradycardia. Known second- or third-degree AV block without pacemaker Dyspnea (NYHA III/IV), wheezing asthma or COPD. Coronary artery bypass graft (CABG) surgery within 90 days prior to screening or at any time after consent. Percutaneous coronary intervention (PCI) within 90 days prior to screening or at any time following consent. Acute myocardial infarction or acute coronary syndrome within 60 days prior to screening or at any time following consent. Any scheduled surgery during the trial period, including dental. Concomitant therapy with strong cytochrome CYP 3A inhibitor or inducer. Recent use of dipyridamole, dipyridamole-containing medications (e.g. Aggrenox) Known hypersensitivity to the investigational drug or any of its components. Known hypersensitivity to adenosine. Lactose intolerance Breastfeeding or pregnancy. Claustrophobia or inability to lie still in a supine position Unwillingness to provide informed consent

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Terrence Ruddy, MD

Organizational Affiliation

Ottawa Heart Institute Research Corporation

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Ottawa Heart Institute

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1Y 4W7

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

28465300

Citation

Pelletier-Galarneau M, Hunter CRRN, Ascah KJ, Beanlands RSB, Dwivedi G, deKemp RA, Chow BJW, Ruddy TD. Randomized Trial Comparing the Effects of Ticagrelor Versus Clopidogrel on Myocardial Perfusion in Patients With Coronary Artery Disease. J Am Heart Assoc. 2017 May 2;6(5):e005894. doi: 10.1161/JAHA.117.005894.

Results Reference

derived

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Ticagrelor vs Clopidogrel Effect on MFR in CAD Population

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