Acute Coronary SyndromesPhase 3SWITCHIIINCT00464087

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

A Phase 3 study testing Switching from Fondaparinux to Bivalirudin or Unfractionated Heparin in people with Acute Coronary Syndromes, run by Medstar Health Research Institute at 7 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective of this clinical trial is to evaluate safety of switching from fondaparinux to either unfractionated heparin or bivalirudin for patients experiencing acute coronary syndrome undergoing percutaneous coronary angioplasty. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Coronary Syndromes
What is being tested?: Switching from Fondaparinux to Bivalirudin or Unfractionated Heparin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 7 sitesin 2 countries
Study dates: Jun 2007to Nov 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1. The patient is, male or female, > 18 years of age; 2. The patient presents with coronary syndrome, unstable angina or non ST segment elevated myocardial infarction (NSTEMI) defined as at least one of the following criteria:
Elevated creatine kinase MB or Troponin I or T (above ULN)
ECG changes indicative of ischemia 3. The patient is scheduled for angiography, with possible angioplasty, evaluation of their coronary disease; 4. The patient is able and willing to conform to the requirements of the study and voluntarily signs an Informed Consent.
ST elevated myocardial infarction within the preceding 48 hours;
Patient weighs more than 400 lbs (181.2 kg) or less than 110 lbs (50 kg);
Patients presenting on or received bivalirudin, GP IIb/IIIa inhibitors or low-molecular weight heparin within the preceding 24 hours;

Show all 20Show fewer

Patients that received unfractionated heparin less than or equal to 90 minutes prior to fondaparinux administration.
Patients with known conditions of bleeding diathesis or actively bleeding within the previous 6 months (GI bleed etc.);
Known diagnosis of acute bacterial endocarditis;
Patients with cardiogenic shock or required intra-aortic balloon pump (IABP)
If patient is on warfarin (Coumadin) therapy;
Patients who had a major or minor stroke (CVA or TIA) or major surgery within the past 6 months;
Known impaired renal function (creatinine ≥ 3.0 mg/dL (265.2 μmol/L),) status post renal transplant, patients on chronic dialysis or creatinine clearance ≤ 30 ml/min;
A platelet count of less than 100,000 cells/mm3;
Known allergies to fondaparinux, aspirin, clopidogrel bisulfate (PlavixR), ticlopidine (TiclidR), heparin, bivalirudin, or contrast that cannot be medically managed;
Prior angioplasty within the previous 30 days;
Contraindication to low-molecular weight heparin, unfractionated heparin or bivalirudin;
Pregnant or lactating women;
Any significant medical condition, which in the investigator's opinion, may interfere with the patient's optimal participation in the study;
Currently participating in an investigational drug or another device study.

Who cannot join

None listed.

Trial locations and contacts

7 sites in 2 countries.

Country

City, postcode or hospital

7 sites in 2 countries

United States5 sites

Bridgeport Hospital
Bridgeport, Connecticut, 06610
University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, 27599
Baptist Cardiac and Vascular Institute
Miami, Florida, 33176
Stony Brook University Medical Center
Stony Brook, New York, 11794
Washington Hospital Center
Washington D.C., District of Columbia, 20010

Other trials in United States

Canada2 sites

Hamilton General Hospital
Hamilton, Ontario, L8L2X2
Institut Universitaire de cardiologie et de Pneumologie de Québec (Hôpital Laval)
Québec, Quebec, G1V 4G5

Other trials in Canada

About this study

Official title: Switching From Arixtra (Fondaparinux) to Angiomax (Bivalirudin) or Unfractionated Heparin in Patients With Acute Coronary Syndromes (ACS) Without ST-segment Elevation Undergoing Percutaneous Coronary Intervention (PCI): SWITCH III

Read the detailed description

This is a prospective open label, randomized, multi-center registry. One hundred patients who received fondaparinux within the 24 hours prior to presentation to the coronary catheterization lab and who are suitable for percutaneous coronary intervention. The patients will be randomized in a 1:1 fashion to either unfractionated heparin or bivalirudin during the angioplasty. All patients will be followed throughout the duration of the hospital stay.

Conditions: Acute Coronary Syndromes
Being tested: Switching from Fondaparinux to Bivalirudin or Unfractionated Heparin
Medical subject headings: Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Switching from Fondaparinux to Bivalirudin or Unfractionated HeparinDrug

Study groups in NCT00464087
Study group	Role	What they receive
Heparin	Active comparator	Patients are switched from fondaparinux to heparin, receiving a dose of 60 U/Kg IV during the PCI Receives: Drug: Switching from Fondaparinux to Bivalirudin or Unfractionated Heparin
Bivalirudin	Active comparator	Patients switched from fondaparinux to bivalirudin, received a bolus of 0.75 mg/kg IV followed by infusion of 1.75 mg/g per hour infusion during the PCI. Receives: Drug: Switching from Fondaparinux to Bivalirudin or Unfractionated Heparin

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Characterized as Fatal bleed, Major bleed (SWITCH III criteria) or major bleed (OASIS criteria)
Measured: During hospitalization, after Fondaparinux administration, prior to randomization
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
Categorized as Fatal bleed, major bleed (SWITCH III criteria) or major bleed (OASIS criteria)
Measured: During hospitalization, after randomization, during PCI
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
Characterized as fatal bleed, major bleed (SWITCH III criteria) or major bleed (OASIS criteria)
Measured: During hospitalization, after PCI

Secondary outcomes (1)

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
Characterized as death, access site complication, access site thrombus, hematoma, myocardial infarction, repeat vascularization, dissection, stent thrombosis, catheter thrombosis
Measured: during index hospitalization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2007Nov 2010

First posted20 Apr 2007 (estimated)
Study startJun 2007
Primary completionNov 2010
Study completionNov 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute Coronary SyndromesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00464087
Sponsor's protocol ID: SWITCH III
Acronym: SWITCHIII
Status last verified: Jul 2013
First submitted: 19 Apr 2007
Last updated: 1 Aug 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Switching From Arixtra (Fondaparinux) to Angiomax (Bivalirudin) or Unfractionated Heparin in Patients With Acute Coronary Syndromes (ACS) Without ST-segment Elevation Undergoing Percutaneous Coronary Intervention (PCI): SWITCH III
ClinicalTrials.gov ID: NCT00464087
Acronym / sponsor ID: SWITCHIII / SWITCH III
Conditions: Acute Coronary Syndromes
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Medstar Health Research InstituteUniversity, hospital or other
Collaborators: GlaxoSmithKline
Study start: Jun 2007
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 20 Apr 2007 (estimated)
Results: Posted 1 Aug 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Heparin	Active comparator	Drug: Switching from Fondaparinux to Bivalirudin or Unfractionated HeparinPatients are switched from fondaparinux to heparin, receiving a dose of 60 U/Kg IV during the PCI
Bivalirudin	Active comparator	Drug: Switching from Fondaparinux to Bivalirudin or Unfractionated HeparinPatients switched from fondaparinux to bivalirudin, received a bolus of 0.75 mg/kg IV followed by infusion of 1.75 mg/g per hour infusion during the PCI.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (20 listed)

1. The patient is, male or female, > 18 years of age; 2. The patient presents with coronary syndrome, unstable angina or non ST segment elevated myocardial infarction (NSTEMI) defined as at least one of the following criteria:
Elevated creatine kinase MB or Troponin I or T (above ULN)
ECG changes indicative of ischemia 3. The patient is scheduled for angiography, with possible angioplasty, evaluation of their coronary disease; 4. The patient is able and willing to conform to the requirements of the study and voluntarily signs an Informed Consent.

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Switching from Fondaparinux to Bivalirudin or Unfractionated Heparin	Drug	Bivalirudin, Heparin

Primary outcome

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
Time frame: During hospitalization, after Fondaparinux administration, prior to randomization
Characterized as Fatal bleed, Major bleed (SWITCH III criteria) or major bleed (OASIS criteria)
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
Time frame: During hospitalization, after randomization, during PCI
Categorized as Fatal bleed, major bleed (SWITCH III criteria) or major bleed (OASIS criteria)
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
Time frame: During hospitalization, after PCI
Characterized as fatal bleed, major bleed (SWITCH III criteria) or major bleed (OASIS criteria)

1 secondary outcome

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
Time frame: during index hospitalization

Results and safety

Results posted to the registry on 1 Aug 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Heparin	49	49
Bivalirudin	51	51
Screen Failures	29	0

Primary outcome: 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

Time frame: During hospitalization, after Fondaparinux administration, prior to randomization. Number. Unit: participants

Measure	Heparin n = 49	Bivalirudin n = 51	Screen Failures n = 0
Value	0	0	–

Primary outcome: 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

Time frame: During hospitalization, after randomization, during PCI. Number. Unit: participants

Measure	Heparin n = 49	Bivalirudin n = 51	Screen Failures n = 0
Value	0	0	–

Primary outcome: 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

Time frame: During hospitalization, after PCI. Number. Unit: participants

Measure	Heparin n = 49	Bivalirudin n = 51	Screen Failures n = 0
Value	0	1	–

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Heparin	0 of 49 (0%)	4 of 49 (8.2%)	Not reported
Bivalirudin	1 of 51 (2%)	4 of 51 (7.8%)	Not reported
Screen Failures	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): This trial included only small number of patients and is not powered to detect intergroup differences

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Acute Coronary Syndromes

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ron Waksman, MD principal investigator

Washington Hospital Center, Washington, DC

7 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: During hospitalization, after Fondaparinux administration, prior to randomization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00464087.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2013.