Bridging Therapy in Patients at High Risk for Stent Thrombosis Undergoing Surgery - Full Text View

Sponsored by:	Cedars-Sinai Medical Center
Information provided by:	Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:	NCT00653601

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:	Case Control, Prospective
Official Title:	Bridging Therapy in Patients at High Risk for Stent Thrombosis Undergoing Surgery

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack Surgery

U.S. FDA Resources

Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:

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 ]

Secondary Outcome 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 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

Biospecimen Description:

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

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

Study Population

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653601

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

Sponsors and Collaborators

Cedars-Sinai Medical Center

Investigators

Principal Investigator:

Sanjay Kaul, MD

Attending physician

More Information

No publications provided

Responsible Party:	CSMC ( Dr Sanjay Kaul, PI )
Study ID Numbers:	Pro00014008
Study First Received:	April 2, 2008
Last Updated:	September 3, 2009
ClinicalTrials.gov Identifier:	NCT00653601 History of Changes
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

Study placed in the following topic categories:

Embolism and Thrombosis
Embolism
Tirofiban
Vascular Diseases

Hemorrhage
PS-K
Thrombosis

Additional relevant MeSH terms:

Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on September 10, 2009