Bridging Therapy in Patients at High Risk for Stent Thrombosis Undergoing Surgery

NCT00653601 | Unknown

• 1 other identifier: Pro00014008
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  until discharge

Secondary Outcomes (2)

• 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 loading dose of clopidogrel.

  until discharge

• 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.

  until discharge

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

2 mL of blood for testing X 5 per patient

MeSH Terms

Conditions

Hemorrhage; Thrombosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sanjay Kaul, MD

  Attending physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 2, 2008
• First Posted: April 7, 2008
• Study Start: April 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: September 4, 2009

Record last verified: 2009-09

Locations

US (1)