Maintenance of platelet inhiBition with cangreloR after dIscontinuation ofthienopyriDines in patients undergoing surGEry: The BRIDGE trial - BRIDGE

• Conditions: Subjects who present with an acute coronary syndrome.; MedDRA version: 12.0Level: LLTClassification code 10051592Term: Acute coronary syndrome; MedDRA version: 12.0Level: PTClassification code 10051592Term: Acute coronary syndrome; MedDRA version: 12.0Level: LLTClassification code 10006894Term: CABG

• Registration Number: EUCTR2008-001135-35-NL
• Lead Sponsor: The Medicines Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

1. Provide written informed consent before initiation of any study related procedures.
2. Be at least 18 years of age.
3. Anticipate non-emergent coronary artery bypass graft (CABG) surgery, either onpump” or off-pump,” no sooner than 48 hours from randomization but no longer than 7 days from randomization, with patient to remain hospitalized until planned CABG.
4. Have received a thienopyridine (at least 75 mg of clopidogrel or 500 mg ticlopidine)
within 48 hours prior to enrollment in the study for the treatment of an acute coronary syndrome or as long-term preventative therapy following drug-eluting stent treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Confirmed of suspected pregnancy (if woman of child-bearing potential) or lactating females
2. Cerebrovascular accident within one year
3. Intracranial neoplasm or history of intracranial surgery
4. History of bleeding diathesis
5. Thrombocytopenia (platelet count of less than 100,000/µL)
6. Known International Normalized Ratio (INR) greater than 1.5 at screening.
7. Requirement for dialysis treatment (hemodialysis or peritoneal)
8. Estimated Glomeular filtration rate eGFR <30 ml/min
9. Administration of abciximab within 24 hours of randomization or administration of
eptifibitide or tirofiban within 12 hours of randomization.
10. Plans to continue oral anticoagulant, thienopyridine or GPIIb/IIIa antagonist therapy
in the pre-operative period.
11. Need of planned concomitant valvular heart surgery
12. Refusal to receive blood transfusion
13. Receipt of fibrinolytic therapy in the 12 hours preceding randomization
14. Allergy, hypersensitivity, or contraindication to cangrelor, mannitol, sorbitol, or
microcrystalline cellulose
15. High likelihood of being unavailable for follow-up
16. Participation in other clinical research studies involving the evaluation of other
investigational drugs or devices within 30 days of randomization
17. Any disease or condition which, in the judgment of the investigator, would place the patient at undue risk by being enrolled in the trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified