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

Microvascular Angina Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02284048
• Other study ID #: ISSBRIL0217
• Status: Not yet recruiting
• Phase: Phase 4
• First received: November 2, 2014
• Last updated: November 5, 2014
• Start date: November 2014
• Est. completion date: November 2017

Study information

• Verified date: November 2014
• Source: Second Xiangya Hospital of Central South University
• Contact: Daoquan Peng, MD, PhD
• Phone: 86-731-85295806
• Email: pengdq[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: November 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris
• Microvascular Angina

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Xiangya Hospital of Central South University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adenosine-induced coronary flow reserve (CFR)		2 months	No