Bridging Therapy in Patients at High Risk for Stent Thrombosis Undergoing Surgery
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition |
|---|
|
Bleeding Thrombosis |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Bridging Therapy in Patients at High Risk for Stent Thrombosis Undergoing Surgery |
- 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 ] [ Designated as safety issue: No ]
- 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. [ Time Frame: until discharge ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples Without DNA
2 mL of blood for testing X 5 per patient
| Estimated Enrollment: | 20 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | April 2011 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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.
|
Detailed Description:
A. D/C clopidogrel 5 days prior to surgery
B. Continue ASA (Increase dose to 325 mg until prohibitive bleeding risk)
C. Check baseline IIb/IIIa and P2Y12 via the Verify Now device prior to initiating tirofiban
D. Start Tirofiban 2 days prior to the procedure (Patient MUST be on a monitored bed)
- Load Tirofiban ONLY if P2Y12 (Verify Now Assay) platelet inhibition is < 20% OTHERWISE initiate only the continuous infusion dose
- Creatinine clearance > 30mL/min: Tirofiban 0.4 mcg/kg/min for 30 minutes, followed by continuous infusion at 0.1 mcg/kg/min
- Creatinine clearance < 30mL/min: Tirofiban 0.2 mcg/kg/min for 30 minutes, followed by continuous infusion of 0.05 mcg/kg/min
E. Check steady state IIb/IIIa inhibitor verify now assay (>8 hour after initiation)
F. Hold Tirofiban 12 hours prior to procedure
G. Check IIb/IIIa inhibitor verify now assay (10-12 hours after Tirofiban is discontinued)
H. CBC pre and post op
I. Reload clopidogrel> 24 hours post op (300 mg X 1 then 75 mg daily) unless prohibitive bleeding risk
J. Reduce ASA to pre-procedure dose. Restart ASA, 24 hours port-op if it was D/C prior to procedure
K. Check P2Y12 via the Verify Now device post-loading dose of clopidogrel (test cannot be performed w/in 48 hours of the D/C of IIb/IIIa inhibitor (tirofiban)
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients' with BMS/DES on plavix prior to surgery who are in need of an elective procedures
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
Contacts and Locations| United States, California | |
| Cedars-Sinai Medical Center | Recruiting |
| Los Angeles, California, United States, 90048 | |
| Contact: Sanjay Kaul, MD 310-423-4876 sanjay.kaul@cshs.org | |
| Contact: Suhail Dohad, MD 310-278-3400 dohad@cvmg.com | |
| Principal Investigator: Sanjay Kaul, MD | |
| Sub-Investigator: Amanda B Lamer, PharmD | |
| Sub-Investigator: Hai Tran, PharmD | |
| Sub-Investigator: Stanley Chou, MD | |
| Sub-Investigator: Suhail Dohad, MD | |
| Principal Investigator: | Sanjay Kaul, MD | Attending physician |
More Information
No publications provided
| Responsible Party: | Dr Sanjay Kaul, PI, CSMC |
| ClinicalTrials.gov Identifier: | NCT00653601 History of Changes |
| Other Study ID Numbers: | Pro00014008 |
| Study First Received: | April 2, 2008 |
| Last Updated: | September 3, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Cedars-Sinai Medical Center:
|
GPI glycoprotein IIb/IIIa inhibitor Aggrastat Tirofiban |
Verify now platelet function testing bridge therapy |
Additional relevant MeSH terms:
|
Hemorrhage Thrombosis Pathologic Processes |
Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 22, 2013