Trial Outcomes & Findings for (A Novel Pharmacologic Regime for Elective Percutaneous Coronary Intervention) (NCT NCT01031095)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

200 participants

Primary outcome timeframe

30 days

Results posted on

2014-01-30

Participant milestones
Measure	Low Dose Intracoronary Heparin Low dose intracoronary heparin treatment arm	Standard Therapy standard unfractionated heparin (UFH) treatment
Overall Study STARTED	100	100
Overall Study COMPLETED	100	100
Overall Study NOT COMPLETED	0	0

Withdrawal data not reported

(A Novel Pharmacologic Regime for Elective Percutaneous Coronary Intervention)

Baseline characteristics by cohort
Measure	Low Dose Intracoronary Heparin n=100 Participants Low dose intracoronary heparin treatment arm	Standard Therapy n=100 Participants standard UFH treatment	Total n=200 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	80 Participants n=93 Participants	80 Participants n=4 Participants	160 Participants n=27 Participants
Age, Categorical >=65 years	20 Participants n=93 Participants	20 Participants n=4 Participants	40 Participants n=27 Participants
Age, Continuous	59.11 years STANDARD_DEVIATION 9.68 • n=93 Participants	58.99 years STANDARD_DEVIATION 11.24 • n=4 Participants	59.06 years STANDARD_DEVIATION 10.46 • n=27 Participants
Sex: Female, Male Female	25 Participants n=93 Participants	19 Participants n=4 Participants	44 Participants n=27 Participants
Sex: Female, Male Male	75 Participants n=93 Participants	81 Participants n=4 Participants	156 Participants n=27 Participants
Region of Enrollment Turkey	100 participants n=93 Participants	100 participants n=4 Participants	200 participants n=27 Participants

Timeframe: 30 days

Outcome measures
Measure	Standard Therapy n=100 Participants standard UFH treatment (intravenous standard dose unfractioned heparin group)
Major Adverse Cardiac Events	2 percentage of event

Timeframe: 30 days

Outcome measures
Measure	Standard Therapy n=100 Participants standard UFH treatment (intravenous standard dose unfractioned heparin group)
Major Adverse Cardiac Event	1 percentage of event

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	Low Dose Intracoronary Heparin n=100 participants at risk Low dose intracoronary heparin treatment arm	Standard Therapy n=100 participants at risk standard UFH treatment
Cardiac disorders MI	1.0% 1/100 • Number of events 1	2.0% 2/100 • Number of events 2

Adverse event data not reported

Bursa Postgraduate Hospital

Phone: 00902243605050