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Effect of Ticagrelor on Adenosine-Induced Coronary Flow Reserve in Patients With Microvascular Angina

Primary Purpose

Microvascular Angina

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
ticagrelor
Sponsored by
Second Xiangya Hospital of Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Microvascular Angina focused on measuring Ticagrelor, Coronary Flow Reserve

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

For inclusion in the study subjects should fulfill the following criteria:

  1. Provision of informed consent prior to any study specific procedures
  2. Female or male aged 18-80 years
  3. A diagnosis of stable primary MVA based on the presence of

    • a history of typical effort angina,
    • exercise-induced ST-segment depression>1 mm,
    • normal or near-normal (coronary artery stenosis<50%) coronary angiography,
    • absence vasospastic angina
    • a coronary flow reserve (CFR) <2.5 in the left anterior descending coronary artery as assessed by coronary blood flow (CBF) response to adenosine at transthoracic Doppler echocardiography
    • suboptimal control of symptoms on conventional anti-ischemic therapy, as indicated by the occurrence of >1 episode per week of angina

Exclusion Criteria:

ubjects should not enter the study if any of the following exclusion criteria are fulfilled:

  1. concomitance with any of the cardiac condition below

    • significant (>50%)coronary plaque disease
    • coronary artery spasm at angiography or other evidence of vasospastic angina
    • valvular or other structural heart disease
    • uncontrolled hypertension
    • abnormal echocardiographic examination including left ventricular hypertrophy
  2. no previous consumption of the ticagrelor
  3. no apparent contraindications to ticagrelor administration.

    • History of Intracranial Hemorrhage
    • Active Bleeding
    • Severe Hepatic Impairment: AST and ALT are greater than 3 times of the upper limit. Bilirubin is greater than the upper limit.
    • hypersensitivity (e.g. angioedema) to ticagrelor or any component of the product
    • severe COPD or asthma

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    control

    ticagrelor

    Arm Description

    nitrate,beta blocker

    ticagrelor 90mg qd

    Outcomes

    Primary Outcome Measures

    adenosine-induced coronary flow reserve (CFR)

    Secondary Outcome Measures

    Full Information

    First Posted
    November 2, 2014
    Last Updated
    November 5, 2014
    Sponsor
    Second Xiangya Hospital of Central South University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02284048
    Brief Title
    Effect of Ticagrelor on Adenosine-Induced Coronary Flow Reserve in Patients With Microvascular Angina
    Official Title
    Effect of Ticagrelor on Adenosine-Induced Coronary Flow Reserve in Patients With Microvascular Angina
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2014 (undefined)
    Primary Completion Date
    November 2016 (Anticipated)
    Study Completion Date
    November 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Second Xiangya Hospital of Central South University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study is undertaken to determine if ticagrelor augments adenosine-induced coronary flow reserve (CFR), ameliorates clinical symptomatology and exercise tolerance in patients with MVA
    Detailed Description
    Considering the reduced CFR and increased platelet aggregability in patients with MVA, together with the augmented effect on adenosine-mediated coronary blood flow and potent antiplatelet effect of ticagrelor, we speculate that ticagrelor can promisingly ameliorate the coronary microvascular function in patients with MVA.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Microvascular Angina
    Keywords
    Ticagrelor, Coronary Flow Reserve

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    140 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    control
    Arm Type
    Placebo Comparator
    Arm Description
    nitrate,beta blocker
    Arm Title
    ticagrelor
    Arm Type
    Active Comparator
    Arm Description
    ticagrelor 90mg qd
    Intervention Type
    Drug
    Intervention Name(s)
    ticagrelor
    Other Intervention Name(s)
    Brilinta
    Intervention Description
    compare the effect of ticagrelor and control on the Coronary Flow Reserve in patients with microvessel angian
    Primary Outcome Measure Information:
    Title
    adenosine-induced coronary flow reserve (CFR)
    Time Frame
    2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: For inclusion in the study subjects should fulfill the following criteria: Provision of informed consent prior to any study specific procedures Female or male aged 18-80 years A diagnosis of stable primary MVA based on the presence of a history of typical effort angina, exercise-induced ST-segment depression>1 mm, normal or near-normal (coronary artery stenosis<50%) coronary angiography, absence vasospastic angina a coronary flow reserve (CFR) <2.5 in the left anterior descending coronary artery as assessed by coronary blood flow (CBF) response to adenosine at transthoracic Doppler echocardiography suboptimal control of symptoms on conventional anti-ischemic therapy, as indicated by the occurrence of >1 episode per week of angina Exclusion Criteria: ubjects should not enter the study if any of the following exclusion criteria are fulfilled: concomitance with any of the cardiac condition below significant (>50%)coronary plaque disease coronary artery spasm at angiography or other evidence of vasospastic angina valvular or other structural heart disease uncontrolled hypertension abnormal echocardiographic examination including left ventricular hypertrophy no previous consumption of the ticagrelor no apparent contraindications to ticagrelor administration. History of Intracranial Hemorrhage Active Bleeding Severe Hepatic Impairment: AST and ALT are greater than 3 times of the upper limit. Bilirubin is greater than the upper limit. hypersensitivity (e.g. angioedema) to ticagrelor or any component of the product severe COPD or asthma
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Daoquan Peng, MD, PhD
    Phone
    86-731-85295806
    Email
    pengdq@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Daoquan Peng, MD, PhD
    Organizational Affiliation
    Second Xiangya Hospital of Central South University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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