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

Purpose

The purpose of this study is to determine if Ticagrelor increases the Adenosin induced coronary blood flow velocity.

Condition	Intervention	Phase
Blood Flow Speed Coronary Flow Velocity	Drug: AZD6140 Drug: Placebo	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Drug Information available for: Adenosine Ticagrelor

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]


Enrollment:	39
Study Start Date:	December 2010
Study Completion Date:	April 2011
Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Adenosinladder; Ticagrelor (180 mg), Adenosinladder ; Theophylline (5 mg/kg), Adenosinladder	Drug: AZD6140 P2Y12 receptor antagonist Other Name: Ticagrelor
Placebo Comparator: 2 Adenosinladder; Placebo, Adenosinladder; Theophylline (5 mg/kg), Adenosinladder	Drug: Placebo

Eligibility


Ages Eligible for Study:	18 Years to 40 Years (Adult)
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01226602

Locations


Sweden
Research Site
Uppsala, Sweden

Sponsors and Collaborators

AstraZeneca

Investigators


Study Director:	Jay Horrow, MD	AstraZeneca
Principal Investigator:	Marianne Hartford, MD	CTC, Göteborg
Study Chair:	Mirjana Kujacic, MD PhD	AstraZeneca, Mölndal Sweden

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01226602 History of Changes
Other Study ID Numbers:	D5130C00067 2010-021820-91
Study First Received:	October 21, 2010
Last Updated:	February 10, 2012
Health Authority:	Sweden: Medical Products Agency

Keywords provided by AstraZeneca:


Ticagrelor Healthy Coronary flow velocity Adenosine

Additional relevant MeSH terms:


Ticagrelor Adenosine Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action	Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Vasodilator Agents Purinergic P1 Receptor Agonists Purinergic Agonists

ClinicalTrials.gov processed this record on September 30, 2016