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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

Page last updated: August 20, 2015

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