Phase 2
N=48
Does Continued Use of Clopidogrel Into Surgery Cause Increased Perioperative Bleeding?
Clopidogrel
Bottom Line
View on ClinicalTrials.gov: NCT01960296 ↗Enrolled (actual)
48
Serious AEs
4.7%
Results posted
Apr 2017
Primary outcome: Primary: Bleeding-related Re-hospitalization — 1; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Clopidogrel (Drug); Discontinue Clopidogrel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bleeding-related Re-hospitalization |
1; 1 | — |
| PRIMARY Perioperative Bleeding Complications |
0; 0 | — |
| SECONDARY Procedure Estimated Blood Loss |
73.6; 52.1 | — |
| SECONDARY Procedure Time |
114.3; 100.4 | — |
| SECONDARY Average Change in Hematocrit |
-3; -1 | — |
| SECONDARY Average Length of Hospital Stay |
2.2; 2.4 | — |
| SECONDARY Same Day Discharged |
8; 12; 13; 10 | — |
| SECONDARY Development of Myocardial Infarction or Thrombosis |
0; 0 | — |
Summary
Patients who on taking clopidogrel are randomized to either continue clopidogrel into general surgery or discontinue clopidogrel 7 days before surgery. All patients resume clopidogrel after surgery. The investigators track the development of bleeding complications that may develop within 90 days of the surgery. Patients are medically cleared to be in either arm of the study by their cardiologist and surgeon. There is currently no evidence to support for or against the use continuation or discontinuation of clopidogrel prior to general surgery.
Eligibility Criteria
Inclusion Criteria
- taking clopidogrel
- undergoing general surgery
- cleared by both cardiologist and surgery for randomized arm
Exclusion Criteria
- previous history of bleeding complications/bleeding disposition
- no capacity to consent
Data sourced from ClinicalTrials.gov (NCT01960296). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.