Effect of Ticagrelor on Adenosine-Induced Coronary Flow Reserve in Patients With Microvascular Angina
Information source: Second Xiangya Hospital of Central South University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Microvascular Angina
Intervention: ticagrelor (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Second Xiangya Hospital of Central South University Official(s) and/or principal investigator(s): Daoquan Peng, MD, PhD, Study Chair, Affiliation: Second Xiangya Hospital of Central South University
Overall contact: Daoquan Peng, MD, PhD, Phone: 86-731-85295806, Email: pengdq@hotmail.com
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
Clinical Details
Official title: Effect of Ticagrelor on Adenosine-Induced Coronary Flow Reserve in Patients With Microvascular Angina
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: adenosine-induced coronary flow reserve (CFR)
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Daoquan Peng, MD, PhD, Phone: 86-731-85295806, Email: pengdq@hotmail.com Additional Information
Starting date: November 2014
Last updated: November 5, 2014
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