Clinical trial NCT02284048: Effect of Ticagrelor on Adenosine-Induced Coronary Flow Reserve in Patients With Microvascular Angina
Official title: Effect of Ticagrelor on Adenosine-Induced Coronary Flow Reserve in Patients With Microvascular Angina
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Microvascular Angina
Keywords: Ticagrelor
Coronary Flow Reserve
Lead sponsor: Second Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2014-11-05
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

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

Primary outcomes:
measure: adenosine-induced coronary flow reserve (CFR)
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Second Xiangya Hospital of Central South University
name: Daoquan Peng, MD, PhD
role: STUDY_CHAIR
References: