Official Title: “Bridging Therapy in Patients at High Risk for Stent Thrombosis Undergoing Surgery.”

1. 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.

2. We will observe all patients with coronary stents on Plavix and aspirin who are admitted to the hospital for surgery. The bridging therapy group will include those patients who have been prescribed Aggrastat by their primary MD or cardiologist. The control group will include those patients whose primary MD and cardiologist chose not to use bridging therapy.

3. Patients will be identified by consultation from cardiologists and by orders for bridging therapy received by the department of pharmacy. Patients will be informed of the study upon admission, after the ordering of bridging therapy. Final consent will also be obtained at that time.

4. Patients in the study will receive care that is no different from the current standard, other than additional testing by the Verify Now device (an FDA-approved device that only requires a small drop of blood for each sample).

5. No additional followup is planned after discharge.

6. No other sites are involved in this study.

Outcomes of interest that will be evaluated include:

I) Primary Outcomes:

1. Bleeding as assessed by hematocrit values obtained immediately pre-operative, immediately post-operative, and prior to discharge (complete blood count to evaluate hematocrit preoperatively and postoperatively is part of the standard of care). In addition, the use of blood products (pRBCs, platelets, FFP) will be assessed.

2. 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.

II) Secondary Outcome:

Platelet function at four different time points using the Verify Now device (FDA-approved): - T1 - at admission (2-3 days after the discontinuation of Plavix and prior to initiation of Aggrastat infusion) - T2 - 8 hours after initiation of Aggrastat (steady-state levels have been reached) - T3 - pre-operative (at least 10-12hrs after Aggrastat infusion has been stopped to allow for complete clearance of the drug from the circulation) - T4 - post-operative (12hrs).

Study Type: Observational

Study Design: Case Control, Prospective

Study Primary Completion Date: April 2009

Arms, Groups and Cohorts in this Clinical Trial

• : 1
  • Patients who receive bridge therapy previously on plavix for DES/BMS prior to scheduled invasive procedures
• : 2
  • Patients who do NOT receive bridge therapy previously on plavix for DES/BMS prior to scheduled invasive procedures Matching case-control # of RF for stent thrombosis types of stents time frame when the stents were placed procedure type

Primary Measures

• Bleeding as assessed by hematocrit values obtained immediately pre-operative, immediately post-operative, and prior to discharge In addition, the use of blood products (pRBCs, platelets, FFP) will be assessed.
  • Time Frame: until discharge
    Safety Issue?: Yes
• 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
    Safety Issue?: No

Secondary Measures

• Platelet function using the Verify Now device: T1 - at admission (2-3 days after the D/C of Plavix and prior to initiation of Aggrastat infusion); T2 - 8 hours after initiation of Aggrastat; T3 - pre-operative; T4 - post-operative (12hrs).
  • Safety Issue?: Yes

Inclusion Criteria:

• Patients' with BMS/DES on plavix prior to surgery who are in need of an elective cardiac, vascular or neurosurgical procedure

Exclusion Criteria:

• Patients' with BMS/DES on NOT plavix prior to surgery who are in need of an elective cardiac, vascular or neurosurgical procedure

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Cedars-Sinai Medical Center

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00653601

Study ID Number: Pro00014008

ClinicalTrials.gov Identifier: NCT00653601

Health Authority: United States: Institutional Review Board