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

November 5, 2014 updated by: Daoquan Peng, Second Xiangya Hospital of Central South University
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: control
nitrate,beta blocker
Drug: ticagrelor
compare the effect of ticagrelor and control on the Coronary Flow Reserve in patients with microvessel angian
Other Names:
  • Brilinta
Active Comparator: ticagrelor
ticagrelor 90mg qd
Drug: ticagrelor
compare the effect of ticagrelor and control on the Coronary Flow Reserve in patients with microvessel angian
Other Names:
  • Brilinta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
adenosine-induced coronary flow reserve (CFR)
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Xiangya Hospital of Central South University

Investigators

  • Study Chair: Daoquan Peng, MD, PhD, Second Xiangya Hospital of Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

November 1, 2017

Study Registration Dates

First Submitted

November 2, 2014

First Submitted That Met QC Criteria

November 4, 2014

First Posted (Estimate)

November 5, 2014

Study Record Updates

Last Update Posted (Estimate)

November 6, 2014

Last Update Submitted That Met QC Criteria

November 5, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISSBRIL0217

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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