Last updated: 11/07/2018 01:03:09
An Open-label, Multicenter, Adaptive Design, Pilot Trial to Examine the Safety and Effectiveness of Argatroban in Combination with Abciximab, a Platelet GP IIb/IIIa Receptor Antagonist in Patients Undergoing Non-urgent Percutaneous Coronary Intervention
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: An Open-label, Multicenter, Adaptive Design, Pilot Trial to Examine the Safety and Effectiveness of Argatroban in Combination with Abciximab, a Platelet GP IIb/IIIa Receptor Antagonist in Patients Undergoing Non-urgent Percutaneous Coronary Intervention
Trial description: An Open-label, Multicenter, Adaptive Design, Pilot Trial to Examine the Safety and Effectiveness of Argatroban in Combination with Abciximab, a Platelet GP IIb/IIIa Receptor Antagonist in Patients Undergoing Non-urgent Percutaneous Coronary Intervention
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Cox DS, Kleiman NS, Boyle DA, et al. Pharmacokinetics and pharmacodynamics of argatroban in combination with a platelet glycoprotein IIb/IIIa receptor antagonist in patients undergoing percutaneous coronary intervention. J Clin Pharmacol 2004;44:981-990.
IK, Lewis BE, Matthai WH, Kleiman NS. Argatroban anticoagulation in conjunction with glycoprotein IIb/IIIa inhibition in patients undergoing percutaneous coronary intervention: an open-label, nonrandomized pilot study. J Thromb Thrombolysis 2004;18:31-37.
Jang IK, Lewis BE, Matthai WH, Kleiman NS. Argatroban anticoagulation in conjunction with glycoprotein IIb/IIIa inhibition in patients undergoing percutaneous coronary intervention: an open-label, nonrandomized pilot study. J Thromb Thrombolysis 2004;18:31-37.
argatroban and glycoprotein 11b/ii1a inhibitor art effeetive and safe in patients undergoing pereutaneous coronary intervention: a prospective, open-label, dose-response study. LK. Jangl, B. E. Lewis, W.H.Vatthai, N.S. Kleiman. 15th Transcatheter Cardiovascular Therapeutics Annual Meeting (TCT) 9/15/2003 Washington, DC
argatroban anticoagulation during percutaneous coronary intervention in patients with heparin-induced thrombocytopenia. Lewis, B. E., Matthai, W. H. Jr, Cohen, M., Moses, J. W., Hursting, M. J., and Leya, F. Catheter Cardiovasc Interv 2002; 57(2):177-84
argatroban anticoagulation inhibits thrombin generation and its rebound during percutaneous interventional procedures. Fareed J., Lewis B. lqbal O. Walenga J. Wrona L. Messmore H. Leya F. 19th Congress of the International Society on Thrombosis and Haemostasis and 49th Annual Scientific and Standardisation Committee Meeting 7/12/2003 Birmingham, UK
combination of a direct thrombin inhibitor, argatroban, and glycoproteln ilb/illa inhibitor is effective and safe in patients undergoing percutaneous coronary intervention. lk-Kyunq Jang, Bruce E. Lewis William H. Maithal Neal S. Kleiman 52nd Annual Scientific Session of the American College of Cardiology 3/30/2003 Chicago, Illinois
Medical condition
Thromboembolism
Product
argatroban
Collaborators
Not applicable
Study date(s)
September 2001 to September 2002
Type
Not applicable
Phase
2
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2002-30-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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