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

NCT ID: NCT02284048

Last Updated: 2014-11-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2017-11-30

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.

Conditions

Microvascular Angina

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

control

nitrate,beta blocker

Group Type: PLACEBO_COMPARATOR

ticagrelor

Intervention Type: DRUG

compare the effect of ticagrelor and control on the Coronary Flow Reserve in patients with microvessel angian

ticagrelor

ticagrelor 90mg qd

Group Type: ACTIVE_COMPARATOR

ticagrelor

Intervention Type: DRUG

compare the effect of ticagrelor and control on the Coronary Flow Reserve in patients with microvessel angian

Interventions

ticagrelor

compare the effect of ticagrelor and control on the Coronary Flow Reserve in patients with microvessel angian

Intervention Type: DRUG

Other Intervention Names

Brilinta

Eligibility 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Daoquan Peng

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daoquan Peng, MD, PhD

Role: STUDY_CHAIR

Second Xiangya Hospital of Central South University

Central Contacts

Daoquan Peng, MD, PhD

Role: CONTACT

pengdq@hotmail.com

86-731-85295806

Other Identifiers

ISSBRIL0217

Identifier Type: -

Identifier Source: org_study_id