Trial Outcomes & Findings for Switching From Fondaparinux to Bivalirudin or Unfractionated Heparin in ACS Patients Undergoing PCI (NCT NCT00464087)

NCT ID: NCT00464087

Last Updated: 2013-08-01

Results Overview

Characterized as Fatal bleed, Major bleed (SWITCH III criteria) or major bleed (OASIS criteria)

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 100 participants
• Primary outcome timeframe: During hospitalization, after Fondaparinux administration, prior to randomization
• Results posted on: 2013-08-01

Participant Flow

Patients who were enrolled and received fondaparinux and who did not have sufficient disease requiring any revascularization procedure will be followed through the duration of the hospitalization. Patients will have a complete blood count (CBC) prior to discharge. These patients are enrolled, but considered screen failures.

Participant milestones

Measure	Heparin All patients received fondaparinux at a dose of 2.5 mg subcutaneously no more than 24 hours before angioplasty. They are randomized to unfractionated heparin during angioplasty and receive a minimum dose of 60 U/kg IV.	Bivalirudin All patients received fondaparinux at a dose of 2.5 mg subcutaneously no more than 24 hours before angioplasty. They are randomized to Bivalirudin during angioplasty and receive a minimum dose of bolus 0.75 mg/kg IV followed by, infusion of 1.75 mg/kg/hr for the duration of the PCI.	Screen Failures These patients were enrolled because they received study drug, but did not have enough disease to require PCI.
Overall Study STARTED	49	51	29
Overall Study COMPLETED	49	51	0
Overall Study NOT COMPLETED	0	0	29

Reasons for withdrawal

Measure	Heparin All patients received fondaparinux at a dose of 2.5 mg subcutaneously no more than 24 hours before angioplasty. They are randomized to unfractionated heparin during angioplasty and receive a minimum dose of 60 U/kg IV.	Bivalirudin All patients received fondaparinux at a dose of 2.5 mg subcutaneously no more than 24 hours before angioplasty. They are randomized to Bivalirudin during angioplasty and receive a minimum dose of bolus 0.75 mg/kg IV followed by, infusion of 1.75 mg/kg/hr for the duration of the PCI.	Screen Failures These patients were enrolled because they received study drug, but did not have enough disease to require PCI.
Overall Study No PCI per inclusion criteria	0	0	29

Baseline Characteristics

Switching From Fondaparinux to Bivalirudin or Unfractionated Heparin in ACS Patients Undergoing PCI

Baseline characteristics by cohort

Measure	Heparin n=49 Participants unfrationated heparin during angioplasty	Bivalirudin n=51 Participants bivalirudin during angioplasty	Screen Failures n=29 Participants Screen Failures are patients who are enrolled and receive the study drug, but do not have enough disease to have percutaneous coronary intervention.	Total n=129 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants	27 Participants n=7 Participants	22 Participants n=5 Participants	80 Participants n=4 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants	24 Participants n=7 Participants	7 Participants n=5 Participants	49 Participants n=4 Participants
Age Continuous	62.18 years STANDARD_DEVIATION 13.36 • n=5 Participants	63.33 years STANDARD_DEVIATION 12.17 • n=7 Participants	54.45 years STANDARD_DEVIATION 13.62 • n=5 Participants	60.45 years STANDARD_DEVIATION 14.42 • n=4 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	14 Participants n=7 Participants	8 Participants n=5 Participants	40 Participants n=4 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	37 Participants n=7 Participants	21 Participants n=5 Participants	89 Participants n=4 Participants
Region of Enrollment United States	16 participants n=5 Participants	18 participants n=7 Participants	29 participants n=5 Participants	63 participants n=4 Participants
Region of Enrollment Canada	33 participants n=5 Participants	33 participants n=7 Participants	0 participants n=5 Participants	66 participants n=4 Participants

PRIMARY outcome

Timeframe: During hospitalization, after Fondaparinux administration, prior to randomization

Characterized as Fatal bleed, Major bleed (SWITCH III criteria) or major bleed (OASIS criteria)

Outcome measures

Measure	Heparin n=49 Participants unfractionated heparin during angioplasty	Bivalirudin n=51 Participants bivalirudin during angioplasty	Screen Failures Screen Failures are patients who are enrolled and receive the study drug, but do not have enough disease to have percutaneous coronary intervention.
The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge	0 participants	0 participants	—

PRIMARY outcome

Timeframe: During hospitalization, after randomization, during PCI

Categorized as Fatal bleed, major bleed (SWITCH III criteria) or major bleed (OASIS criteria)

Outcome measures

Measure	Heparin n=49 Participants unfractionated heparin during angioplasty	Bivalirudin n=51 Participants bivalirudin during angioplasty	Screen Failures Screen Failures are patients who are enrolled and receive the study drug, but do not have enough disease to have percutaneous coronary intervention.
The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge	0 participants	0 participants	—

PRIMARY outcome

Timeframe: During hospitalization, after PCI

Characterized as fatal bleed, major bleed (SWITCH III criteria) or major bleed (OASIS criteria)

Outcome measures

Measure	Heparin n=49 Participants unfractionated heparin during angioplasty	Bivalirudin n=51 Participants bivalirudin during angioplasty	Screen Failures Screen Failures are patients who are enrolled and receive the study drug, but do not have enough disease to have percutaneous coronary intervention.
The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge	0 participants	1 participants	—

SECONDARY outcome

Timeframe: during index hospitalization

Characterized as death, access site complication, access site thrombus, hematoma, myocardial infarction, repeat vascularization, dissection, stent thrombosis, catheter thrombosis

Outcome measures

Measure	Heparin n=49 Participants unfractionated heparin during angioplasty	Bivalirudin n=51 Participants bivalirudin during angioplasty	Screen Failures Screen Failures are patients who are enrolled and receive the study drug, but do not have enough disease to have percutaneous coronary intervention.
Secondary in Hospital Endpoint Will be In-hospital Death (Non-hemorrhagic Related), Vascular Access Site Complications, Myocardial Infarction, Need for Repeat Revascularization, Procedural Complication and Catheter Thrombosis	4 participants	4 participants	—

Adverse Events

Heparin

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Bivalirudin

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Screen Failures

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Heparin n=49 participants at risk unfrationated heparin during angioplasty	Bivalirudin n=51 participants at risk bivalirudin during angioplasty	Screen Failures Screen Failures are patients who are enrolled and receive the study drug, but do not have enough disease to have percutaneous coronary intervention.
Vascular disorders Major Bleed	0.00% 0/49	2.0% 1/51 • Number of events 1	— 0/0

Other adverse events

Measure	Heparin n=49 participants at risk unfrationated heparin during angioplasty	Bivalirudin n=51 participants at risk bivalirudin during angioplasty	Screen Failures Screen Failures are patients who are enrolled and receive the study drug, but do not have enough disease to have percutaneous coronary intervention.
Vascular disorders Access Site Complication	2.0% 1/49 • Number of events 1	5.9% 3/51 • Number of events 3	— 0/0
Cardiac disorders Dissection	2.0% 1/49 • Number of events 1	2.0% 1/51 • Number of events 1	— 0/0
Cardiac disorders Ventricular fibrillation	2.0% 1/49 • Number of events 1	0.00% 0/51	— 0/0
Cardiac disorders Repeat revascularization	2.0% 1/49 • Number of events 1	0.00% 0/51	— 0/0

Additional Information

Ron Waksman, MD

Medstar Health Research Institute

Phone: 202-877-2812

Email: ron.waksman@medstar.net

Results disclosure agreements

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