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

NCT02284048 | Unknown Phase 4 DMC

• 1 other identifier: ISSBRIL0217
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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

Conditions

Microvascular Angina

Keywords

Ticagrelor; Coronary Flow Reserve

Outcome Measures

Primary Outcomes (1)

• adenosine-induced coronary flow reserve (CFR)

  2 months

Study Arms (2)

control

PLACEBO COMPARATOR

nitrate,beta blocker

Drug: ticagrelor

ticagrelor

ACTIVE COMPARATOR

ticagrelor 90mg qd

Drug: ticagrelor

Interventions

ticagrelor DRUG

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

Also known as: Brilinta

control; ticagrelor

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead

MeSH Terms

Conditions

Microvascular Angina

Interventions

Ticagrelor

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Daoquan Peng, MD, PhD

  Second Xiangya Hospital of Central South University

  STUDY CHAIR

Central Study Contacts

Daoquan Peng, MD, PhD

CONTACT

86-731-85295806; pengdq@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 2, 2014
• First Posted: November 5, 2014
• Study Start: November 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2017
• Last Updated: November 6, 2014

Record last verified: 2014-11