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Study to Assess the Effect of Ticagrelor on Coronary Blood Flow in Healthy Male Subjects.

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: NCT01226602
Recruitment Status : Completed
First Posted : October 22, 2010
Last Update Posted : February 13, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE October 21, 2010
First Posted Date  ICMJE October 22, 2010
Last Update Posted Date February 13, 2012
Study Start Date  ICMJE December 2010
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2010)
  • Assess the effect of Ticagrelor compared to placebo on the adenosine induced coronary blood flow velocity response by estimating the change in area under the adenosine dose response curve before and after study drug. [ Time Frame: During 6 h at visit 2 ]
  • Assess the effect of Ticagrelor compared to placebo on the adenosine induced coronary blood flow velocity response by estimating the change in area under the adenosine dose response curve before and after study drug. [ Time Frame: During 6 h at visit 3 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2010)
  • Effect of Ticagrelor compared to placebo on the adenosine induced coronary blood flow velocity by estimating the change in area under the adenosine dose response curve before and after infusion of theophylline. [ Time Frame: During 6 h at visit 2 ]
  • Difference in basal blood flow (in the absence of adenosine) between Ticagrelor and placebo conditions before and after infusion of theophylline. [ Time Frame: During 6h at visit 2 ]
  • Difference in basal blood flow (in the absence of adenosine) between Ticagrelor and placebo conditions before and after infusion of theophylline. [ Time Frame: During 6 h at visit 3 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess the Effect of Ticagrelor on Coronary Blood Flow in Healthy Male Subjects.
Official Title  ICMJE A Randomized, Double-blind, Placebo Controlled, Crossover, Single Centre Phase I Study to Assess the Effect of Ticagrelor on Adenosine-induced Coronary Blood Flow Velocity in Healthy Male Subjects
Brief Summary The purpose of this study is to determine if Ticagrelor increases the Adenosin induced coronary blood flow velocity.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Blood Flow Speed
  • Coronary Flow Velocity
Intervention  ICMJE
  • Drug: AZD6140
    P2Y12 receptor antagonist
    Other Name: Ticagrelor
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: 1
    Adenosinladder; Ticagrelor (180 mg), Adenosinladder ; Theophylline (5 mg/kg), Adenosinladder
    Intervention: Drug: AZD6140
  • Placebo Comparator: 2
    Adenosinladder; Placebo, Adenosinladder; Theophylline (5 mg/kg), Adenosinladder
    Intervention: Drug: Placebo
Publications * Wittfeldt A, Emanuelsson H, Brandrup-Wognsen G, van Giezen JJ, Jonasson J, Nylander S, Gan LM. Ticagrelor enhances adenosine-induced coronary vasodilatory responses in humans. J Am Coll Cardiol. 2013 Feb 19;61(7):723-7. doi: 10.1016/j.jacc.2012.11.032. Epub 2013 Jan 9.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: April 20, 2011)		 39
Original Estimated Enrollment  ICMJE
 (submitted: October 21, 2010)		 40
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Suitable for ECG recording of CBFV and have no adverse reaction to adenosine challenge
  • Have a body mass index between 18 and 30 kg/m2

Exclusion Criteria:

  • History of clinically significant disease or disorder.
  • Abnormal vital signs
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01226602
Other Study ID Numbers  ICMJE D5130C00067
2010-021820-91 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party AstraZeneca
Original Responsible Party MSD, AstraZeneca
Current Study Sponsor  ICMJE AstraZeneca
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jay Horrow, MD AstraZeneca
Principal Investigator: Marianne Hartford, MD CTC, Göteborg
Study Chair: Mirjana Kujacic, MD PhD AstraZeneca, Mölndal Sweden
PRS Account AstraZeneca
Verification Date February 2012

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