Trial Outcomes & Findings for How Effective Are Antithrombotic Therapies in Primary Percutaneous Coronary Intervention (NCT NCT01519518)

NCT ID: NCT01519518

Last Updated: 2015-05-13

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 1829 participants
• Primary outcome timeframe: 28 days
• Results posted on: 2015-05-13

Participant Flow

Participant milestones

Measure	Unfractionated Heparin 70 units/kg body weight intravenous unfractionated heparin: 70 units/kg body weight intravenous	Bivalirudin intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour
Overall Study STARTED	914	915
Overall Study COMPLETED	907	905
Overall Study NOT COMPLETED	7	10

Reasons for withdrawal

Measure	Unfractionated Heparin 70 units/kg body weight intravenous unfractionated heparin: 70 units/kg body weight intravenous	Bivalirudin intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour
Overall Study Consent not available	7	10

Baseline Characteristics

How Effective Are Antithrombotic Therapies in Primary Percutaneous Coronary Intervention

Baseline characteristics by cohort

Measure	Unfractionated Heparin n=907 Participants 70 units/kg body weight intravenous unfractionated heparin: 70 units/kg body weight intravenous	Bivalirudin n=905 Participants intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour	Total n=1812 Participants Total of all reporting groups
Age, Continuous	63.6 years n=5 Participants	62.9 years n=7 Participants	63.2 years n=5 Participants
Sex: Female, Male Female	244 Participants n=5 Participants	258 Participants n=7 Participants	502 Participants n=5 Participants
Sex: Female, Male Male	663 Participants n=5 Participants	647 Participants n=7 Participants	1310 Participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days

Outcome measures

Measure	Unfractionated Heparin n=907 Participants 70 units/kg body weight intravenous unfractionated heparin: 70 units/kg body weight intravenous	Bivalirudin n=905 Participants intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour
Major Adverse Cardiac Events (MACE) in Terms of the Incidence of All Cause Mortality, Cerebrovascular Accident, Re-infarction and Additional Unplanned Target Lesion Revascularization	5.7 percentage of total participants	8.7 percentage of total participants

PRIMARY outcome

Timeframe: 28 days

Outcome measures

Measure	Unfractionated Heparin n=907 Participants 70 units/kg body weight intravenous unfractionated heparin: 70 units/kg body weight intravenous	Bivalirudin n=905 Participants intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour
Type 3-5 Bleeding According to BARC (Bleeding Academic Research Consortium)Definition	3.1 percentage of total participants	3.5 percentage of total participants

SECONDARY outcome

Timeframe: 28 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days

Outcome measures

Measure	Unfractionated Heparin n=907 Participants 70 units/kg body weight intravenous unfractionated heparin: 70 units/kg body weight intravenous	Bivalirudin n=905 Participants intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour
Minor Bleeding: Type 2 Bleeding According to BARC (Bleeding Academic Research Consortium) Definition	10.8 percentage of total participants	9.2 percentage of total participants

SECONDARY outcome

Timeframe: 28 days

Outcome measures

Measure	Unfractionated Heparin n=907 Participants 70 units/kg body weight intravenous unfractionated heparin: 70 units/kg body weight intravenous	Bivalirudin n=905 Participants intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour
Stent Thrombosis Rate (ARC Definite or Probable)	0.9 percentage of total participants	3.4 percentage of total participants

SECONDARY outcome

Timeframe: 28 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days

Outcome measures

Outcome data not reported

Adverse Events

Unfractionated Heparin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bivalirudin

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

Dr Rod Stables

Liverpool Heart and Chest Hospital

Phone: 01512281616

Email: rod.stables@lhch.nhs.uk

Results disclosure agreements

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