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
About this trial
This is an interventional treatment trial for Microvascular Angina focused on measuring Ticagrelor, Coronary Flow Reserve
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
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
NCT ID
NCT02284048
First Posted
November 2, 2014
Last Updated
November 5, 2014
Sponsor
Second Xiangya Hospital of Central South University
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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Effect of Ticagrelor on Adenosine-Induced Coronary Flow Reserve in Patients With Microvascular Angina
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