Recruiting

Bridging Therapy

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT00653601

Conditions

Bleeding

Thrombosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Patients who have undergone placement of coronary stents require dual antiplatelet therapy with Plavix and aspirin to prevent the serious complication of in-stent thrombosis. Some of these patients will require surgery while on dual antiplatelet therapy. This poses a challenge because being on Plavix is associated with higher risks of perioperative bleeding, but stopping Plavix puts patients at increased risk for in-stent thrombosis.

Currently, the ACC/AHA guidelines recommend discontinuation of Plavix five days prior to surgery to prevent bleeding complications. However, there are no universal recommendations for preventing in-stent thrombosis. Some experts recommend the use glycoprotein IIb/IIIa inhibitors (short-acting antiplatelet agents) as "bridging therapy" during the high-risk perioperative period. Although these agents should be beneficial based on theory, there is currently no published data on their effectiveness for this purpose.

The current study proposes to evaluate the value of Aggrastat (a short-acting intravenous platelet glycoprotein IIb/IIIa inhibitor) in decreasing the risk of in-stent thrombosis without increasing the risk of perioperative bleeding.

Conditions

Bleeding

Thrombosis

Study ID

NCT00653601

Start date

Apr, 2008

Status verified date

Sep, 2009

Completion date

Apr, 2011

Anticipated

Primary completion date

Apr, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients' with BMS/DES on plavix prior to surgery who are in need of an elective procedures

Exclusion Criteria:

  • Patients' with BMS/DES on NOT plavix prior to surgery who are in need of an elective procedures

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

1

Patients who receive bridge therapy with tirofiban who were previously on plavix for drug eluting or bare metal stent prior to scheduled invasive procedures

2

Patients who do NOT receive bridge therapy previously on plavix for drug eluting or bare metal stent prior to scheduled invasive procedures. This will entail of a matching case-control for the following characteristics.

  • # of RF for stent thrombosis
  • types of stents
  • time frame when the stents were placed
  • procedure type

Primary outcome measure

  • In-stent thrombosis as assessed by acute coronary syndromes of unstable angina/non-ST elevation myocardial infarction or ST-elevation myocardial infarction during the hospitalization. [ Time Frame: until discharge ]

Central Contacts and Locations

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Principal Investigator:

Sanjay Kaul, MD

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Sep 4, 2009

Last verified

Sep, 2009

Keywords

  • GPI
  • glycoprotein IIb/IIIa inhibitor
  • Aggrastat
  • Tirofiban
  • Verify now
  • platelet function testing
  • bridge therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2009-09-04.