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Trial record 64 of 1197 for:    adenosine

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02284048
Recruitment Status : Unknown
Verified November 2014 by Daoquan Peng, Second Xiangya Hospital of Central South University.
Recruitment status was:  Not yet recruiting
First Posted : November 5, 2014
Last Update Posted : November 6, 2014
Sponsor:
Information provided by (Responsible Party):
Daoquan Peng, Second Xiangya Hospital of Central South University

Tracking Information
First Submitted Date  ICMJE November 2, 2014
First Posted Date  ICMJE November 5, 2014
Last Update Posted Date November 6, 2014
Study Start Date  ICMJE November 2014
Estimated Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2014)
adenosine-induced coronary flow reserve (CFR) [ Time Frame: 2 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02284048 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Ticagrelor on Adenosine-Induced Coronary Flow Reserve in Patients With Microvascular Angina
Official Title  ICMJE Effect of Ticagrelor on Adenosine-Induced Coronary Flow Reserve in Patients With Microvascular Angina
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Microvascular Angina
Intervention  ICMJE Drug: ticagrelor
compare the effect of ticagrelor and control on the Coronary Flow Reserve in patients with microvessel angian
Other Name: Brilinta
Study Arms  ICMJE
  • Placebo Comparator: control
    nitrate,beta blocker
    Intervention: Drug: ticagrelor
  • Active Comparator: ticagrelor
    ticagrelor 90mg qd
    Intervention: Drug: ticagrelor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 4, 2014)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2017
Estimated Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02284048
Other Study ID Numbers  ICMJE ISSBRIL0217
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daoquan Peng, Second Xiangya Hospital of Central South University
Study Sponsor  ICMJE Second Xiangya Hospital of Central South University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Daoquan Peng, MD, PhD Second Xiangya Hospital of Central South University
PRS Account Second Xiangya Hospital of Central South University
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP