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

NCT01226602 | Completed Phase 1

• 2 other identifiers: D5130C000672010-021820-91
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Blood Flow Speed; Coronary Flow Velocity

Keywords

Ticagrelor; Healthy; Coronary flow velocity; Adenosine

Outcome Measures

Primary Outcomes (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.

  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.

  During 6 h at visit 3

Secondary Outcomes (3)

• 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.

  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.

  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.

  During 6 h at visit 3

Study Arms (2)

1

EXPERIMENTAL

Adenosinladder; Ticagrelor (180 mg), Adenosinladder ; Theophylline (5 mg/kg), Adenosinladder

Drug: AZD6140

2

PLACEBO COMPARATOR

Adenosinladder; Placebo, Adenosinladder; Theophylline (5 mg/kg), Adenosinladder

Drug: Placebo

Interventions

AZD6140 DRUG

P2Y12 receptor antagonist

Also known as: Ticagrelor

1

Placebo DRUG

2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• History of clinically significant disease or disorder.
• Abnormal vital signs

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Uppsala, Sweden

Location

Related Publications (1)

• 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.

  PMID: 23312702 DERIVED

MeSH Terms

Interventions

Ticagrelor

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Jay Horrow, MD

  AstraZeneca

  STUDY DIRECTOR

• Marianne Hartford, MD

  CTC, Göteborg

  PRINCIPAL INVESTIGATOR

• Mirjana Kujacic, MD PhD

  AstraZeneca, Mölndal Sweden

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2010
• First Posted: October 22, 2010
• Study Start: December 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: February 13, 2012

Record last verified: 2012-02

Locations

SE (1)