ClopidogrelPhase 2NCT01960296
Does Continued Use of Clopidogrel Into Surgery Cause Increased Perioperative Bleeding?
A Phase 2 study testing Clopidogrel and Discontinue Clopidogrel in people with Clopidogrel, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Clopidogrel
- What is being tested?
- Clopidogrel and Discontinue Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to May 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- taking clopidogrel
- undergoing general surgery
- cleared by both cardiologist and surgery for randomized arm
Who cannot join
- previous history of bleeding complications/bleeding disposition
- no capacity to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Evaluation of Clopidogrel Use in Peri-Operative General Surgery Patients: A Prospective Study
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.
Read the detailed description
A medical record review was performed of 104 consecutive patients undergoing general surgical procedures while receiving antiplatelet therapy. Patients were identified from an administrative database by crossreferencing clopidogrel with abdominal operative procedures. The records of only patients who were actively receiving antiplatelet therapy, with the last clopidogrel dose within 45 days of their operation, were considered in the study.
- Conditions
- Clopidogrel
- Being tested
- Clopidogrel, Discontinue Clopidogrel
- Keywords
- clopidogrel, general surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
Continue home dose of clopidogrel into surgery
Discontinue ClopidogrelDrug
Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel | Experimental | Continue home dose of clopidogrel into surgery Receives: Drug: Clopidogrel |
| Discontinue | Active comparator | Discontinue home dose of clopidogrel one week before surgery. Resume after surgery. Receives: Drug: Discontinue Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding-related Re-hospitalization
Perioperative Bleeding Complications as indicated by bleeding requiring re-admission.
Measured: up to 90 days post op
Perioperative Bleeding Complications
Development of perioperative bleeding complications as indicated for need for blood transfusions, hematoma, and bleeding requiring re-operation.
Measured: up to 90 days postop
Secondary outcomes (6)
Procedure Estimated Blood Loss
Measured: up to 90 days postop
Procedure Time
Measured: Day 1
Average Change in Hematocrit
hematocrit levels change from preoperative to postoperative
Measured: baseline and Day 1
Average Length of Hospital Stay
Measured: up to 90 days
Same Day Discharged
Number of patients discharged on the day of surgery
Measured: up to 90 days
Development of Myocardial Infarction or Thrombosis
Measured: up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startJan 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ClopidogrelStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Doris Duke Charitable Foundation
- Responsible party
- Sponsor
- Investigators
- Celia M Divino, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01960296
- Sponsor's protocol ID
- GCO 10-1067
- Status last verified
- Apr 2017
- First submitted
- 8 Oct 2013
- Last updated
- 30 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Chernoguz A, Telem DA, Chu E, Ozao-Choy J, Tammaro Y, Divino CM. Cessation of clopidogrel before major abdominal procedures. Arch Surg. 2011 Mar;146(3):334-9. doi: 10.1001/archsurg.2011.23.
PubMed 21422366Chu EW, Chernoguz A, Divino CM. The evaluation of clopidogrel use in perioperative general surgery patients: a prospective randomized controlled trial. Am J Surg. 2016 Jun;211(6):1019-25. doi: 10.1016/j.amjsurg.2015.05.036. Epub 2015 Aug 20.
PubMed 27002953
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clopidogrel Use in Peri-Operative General Surgery Patients: A Prospective Study
- ClinicalTrials.gov ID
- NCT01960296
- Acronym / sponsor ID
- GCO 10-1067
- Conditions
- Clopidogrel
- Keywords
- clopidogrel, general surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Doris Duke Charitable Foundation
- Study start
- Jan 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 10 Oct 2013 (estimated)
- Results
- Posted 28 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A medical record review was performed of 104 consecutive patients undergoing general surgical procedures while receiving antiplatelet therapy. Patients were identified from an administrative database by crossreferencing clopidogrel with abdominal operative procedures. The records of only patients who were actively receiving antiplatelet therapy, with the last clopidogrel dose within 45 days of their operation, were considered in the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel | Experimental | Drug: ClopidogrelContinue home dose of clopidogrel into surgery |
| Discontinue | Active comparator | Drug: Discontinue ClopidogrelDiscontinue home dose of clopidogrel one week before surgery. Resume after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- taking clopidogrel
- undergoing general surgery
- cleared by both cardiologist and surgery for randomized arm
Key exclusion criteria (2 listed)
- previous history of bleeding complications/bleeding disposition
- no capacity to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClopidogrelContinue home dose of clopidogrel into surgery | Drug | Clopidogrel |
| Discontinue ClopidogrelDiscontinue home dose of clopidogrel one week before surgery. Resume after surgery. | Drug | Discontinue |
Primary outcome
Bleeding-related Re-hospitalization
Time frame: up to 90 days post op
Perioperative Bleeding Complications as indicated by bleeding requiring re-admission.
Perioperative Bleeding Complications
Time frame: up to 90 days postop
Development of perioperative bleeding complications as indicated for need for blood transfusions, hematoma, and bleeding requiring re-operation.
6 secondary outcomes
Procedure Estimated Blood Loss
Time frame: up to 90 days postop
Procedure Time
Time frame: Day 1
Average Change in Hematocrit
Time frame: baseline and Day 1
Average Length of Hospital Stay
Time frame: up to 90 days
Same Day Discharged
Time frame: up to 90 days
Development of Myocardial Infarction or Thrombosis
Time frame: up to 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21422366Chernoguz A, Telem DA, Chu E, Ozao-Choy J, Tammaro Y, Divino CM. Cessation of clopidogrel before major abdominal procedures. Arch Surg. 2011 Mar;146(3):334-9. doi: 10.1001/archsurg.2011.23.
- Results publication: PubMed 27002953Chu EW, Chernoguz A, Divino CM. The evaluation of clopidogrel use in perioperative general surgery patients: a prospective randomized controlled trial. Am J Surg. 2016 Jun;211(6):1019-25. doi: 10.1016/j.amjsurg.2015.05.036. Epub 2015 Aug 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Celia M Divino, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clopidogrel and Discontinue Clopidogrel in people with Clopidogrel, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding-related Re-hospitalization (time frame: up to 90 days post op). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01960296, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.