Significance of Antibodies to Heparin/Platelet Factor 4 Complex in Vein Graft Patency and Potential Role of Argatroban for Prevention of Vein Graft Occlusion

Coronary Artery Bypass Graft Surgery Clinical Trial

Official title:

Significance of Antibodies to Heparin/Platelet Factor 4 Complex in Vein Graft Patency and Potential Role of Argatroban for Prevention of Vein Graft Occlusion

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01246011
• Other study ID #: 2010P001386
• Status: Terminated
• Phase: Phase 4
• First received: November 17, 2010
• Last updated: October 16, 2017
• Start date: November 2010
• Est. completion date: July 2011

Study information

• Verified date: October 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Heparin/Platelet Factor 4 (PF4) antibody testing will be performed in subjects who have just undergone coronary artery bypass grafting (CABG) surgery. 30 subjects with a positive antibody result and no signs or symptoms of Heparin Induced Thrombocytopenia (HIT) will be randomized to receive argatroban and warfarin. 30 subjects with a positive antibody result and no signs or symptoms of HIT will be randomized to receive no treatment. 30 subjects with a negative antibody result will also be followed in the study. All subjects will have a cardiac CT scan at about 30 days post surgery to measure the patency of their coronary artery bypass vein grafts. This study will evaluate if treating patients who have heparin PF4 antibodies post-CABG with argatroban and warfarin has any effect on the short-term patency of coronary artery bypass vein grafts.

Description:

This is a prospective, randomized, single center study. Patients scheduled for CABG will be screened and enrolled. Subjects positive for heparin/PF4 antibody within 24 h after CABG and without clinical suspicion of HIT will be randomized into one of two groups. An additional 30 patients with negative antibody titers will serve as a control group.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients scheduled for CABG (males or non-pregnant females)

2. > 18 years old with at least one vein graft planned

3. Able to provide written informed consent

Exclusion Criteria:

1. Patients who, in the investigator's or attending surgeon's opinion, are unsuitable for anticoagulation due to their clinical status

2. Documented history of allergy to iodinated contrast media, warfarin, or argatroban

3. Chronic renal impairment with CrCl<60 ml/min

4. Recent bleeding episode

5. Congestive Heart Failure (EF< 30%)

6. Bleeding diathesis or known thrombophilic disorder

7. Atrial fibrillation or other condition requiring anticoagulation at the time of enrollment

8. Documented history of heparin induced thrombocytopenia

9. Clinical suspicion of HIT at the time of randomization, defined as 50% decrease in Platelet count from last heparin exposure or Platelet count <100,000/ml

10. Hepatic dysfunction (defined as LFTs > 3 times the upper limit of normal)

11. Patients with a history of bleeding complications post-CABG

12. Hemorrhagic stroke

13. Gastrointestinal bleeding

14. Requirement for fresh frozen plasma

15. Recent central nervous system or ophthalmic surgery

16. Aneurysm

17. History of psychosis or senility

18. Malignant hypertension

19. Clinically significant pericarditis or pericardial effusion

20. Bacterial endocarditis

21. Hematocrit < 24%

22. Valve replacement or repair at time of CABG

23. Subjects with signs or symptoms of possible Transient Ischemic Attack or stroke

Related Conditions & MeSH terms

• Coronary Artery Bypass Graft Surgery
• Presence of Heparin/Platelet Factor 4 Antibody

Intervention

Drug:
• Argatroban and warfarin
Subjects with the presence of heparin PF4 antibodies without signs or symptoms of HIT post CABG will be randomized to receive argatroban and warfarin or no drug for one month.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronary Artery Bypass Vein Graft Patency	Vein graft patency as measured by computed tomography	Approximately 30 Days post CABG
Secondary	Major Bleeding Events.	Intracranial bleed or any clinically overt sign of hemorrhage that is associated with a fall in hemoglobin > 5 g/dL.	At 2weeks post CABG