Who is sponsoring NCT00464087?

NCT00464087 is sponsored by Medstar Health Research Institute.

What drugs are being tested in NCT00464087?

Interventions in NCT00464087: Switching from Fondaparinux to Bivalirudin or Unfractionated Heparin.

What condition does NCT00464087 study?

NCT00464087 studies Acute Coronary Syndromes.

Is NCT00464087 still recruiting?

NCT00464087 is currently completed. Last updated 30 July 2013.

Are results published for NCT00464087?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2013-07-30 · How we verify

NCT00464087: SWITCHIII

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Results posted Last updated 30 July 2013

What this trial tests

Phase 3 trial testing Switching from Fondaparinux to Bivalirudin or Unfractionated Heparin in Acute Coronary Syndromes in 100 participants. Completed in 1 November 2010.

Timeline

1 June 2007

Primary endpoint
1 November 2010

1 November 2010

Quick facts

Lead sponsor	Medstar Health Research Institute
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	1 June 2007
Primary completion	1 November 2010
Estimated completion	1 November 2010
Sites	7 locations across United States, Canada

Drugs / interventions tested

Switching from Fondaparinux to Bivalirudin or Unfractionated Heparin — full drug profile →

Conditions studied

Acute Coronary Syndromes — all drugs for Acute Coronary Syndromes →

Sponsor

Medstar Health Research Institute

Who can join

18 and older, any sex, with Acute Coronary Syndromes. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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)

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Acute Coronary Syndromes

Currently open trials in the same condition.

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Other Medstar Health Research Institute trials

Trials by the same sponsor.

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NCT07223489 — Diagnostic Journey, Patient Experience, and Disparities in the Treatment of Spinal Muscular Atrophy (SMA) in the MedStar · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00464087 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Medstar Health Research Institute
Last refreshed: 30 July 2013

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00464087.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing