Trial Outcomes & Findings for Persantine: Variation in Response Trial (NCT NCT00763009)

NCT ID: NCT00763009

Last Updated: 2018-04-13

Results Overview

To determine if there is a subgroup of patients that have an abnormal adenosine transporter expression, or abnormal adenosine transporter protein function. All were responsive Study terminated due to difficulty enrolling

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 8 participants
• Primary outcome timeframe: 6-12 months
• Results posted on: 2018-04-13

Participant Flow

Study terminated due to difficulty enrolling

Study terminated due to difficulty enrolling

Participant milestones

Measure	All Subjects Receive Dipyridamole There is only a single arm dipyridamole: 0.28mg/kg over 4 minutes intravenously x three doses; totalling 0.84mg/kg intravenously
Overall Study STARTED	8
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	All Subjects Receive Dipyridamole There is only a single arm dipyridamole: 0.28mg/kg over 4 minutes intravenously x three doses; totalling 0.84mg/kg intravenously
Overall Study Coronary Anatomy unsuitable	1

Baseline Characteristics

Persantine: Variation in Response Trial

Baseline characteristics by cohort

Measure	Dipyridamole n=8 Participants Pre: Baseline Results prior to administration of Dipyridamole. Post: Results post adminsitration of Dipyridamole
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=93 Participants
Age, Categorical >=65 years	5 Participants n=93 Participants
Age, Continuous	65 years STANDARD_DEVIATION 7 • n=93 Participants
Sex: Female, Male Female	4 Participants n=93 Participants
Sex: Female, Male Male	4 Participants n=93 Participants
Region of Enrollment United States	8 participants n=93 Participants

PRIMARY outcome

Timeframe: 6-12 months

Population: All patients responded. Function and Expression of the Transporter were therefore not performed. The study was terminated due to poor enrollment

To determine if there is a subgroup of patients that have an abnormal adenosine transporter expression, or abnormal adenosine transporter protein function. All were responsive Study terminated due to difficulty enrolling

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6-12 months

Population: The study was terminated due to poor enrollment

Outcome measures

Outcome data not reported

Adverse Events

All Subjects Receive Dipyridamole

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Azrin

UCHC

Phone: 8606793343

Email: azrin@uchc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place