ST-elevation Myocardial InfarctionNCT01991366
Should Integrilin be an Integral Part of Adjunctive Therapy in Patients Undergoing Primary PCI for ST-Elevation MI?
An observational study of ST-elevation Myocardial Infarction and Acute Myocardial Infarction, run by Medstar Health Research Institute at 1 site in United States.
Trial summary
The aim of this observational study is to evaluate the in hospital and 6 month outcomes of the use of Glycoprotein IIb/IIIa inhibitor eptifibatide as adjunctive therapy in patients undergoing primary Percutaneous Coronary Intervention for ST-elevation myocardial infarction in a large tertiary referral center. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ST-elevation Myocardial Infarction, Acute Myocardial Infarction
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who underwent primary Percutaneous Coronary Intervention at Washington Hospital Center since September 2000 and received eptifibatide pre-or during PCI or have received no eptifibatide.
Who may be able to join
- Underwent Percutaneous Coronary Intervention at Washington Hospital Center since September 2000
- Either received eptifibatide pre-or during PCI or have received no eptifibatide.
Who cannot join
- Patients who received a thrombolytic prior to Percutaneous Coronary Intervention.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Should Integrilin be an Integral Part of Adjunctive Therapy in Patients Undergoing Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction?
The aim of this observational study is to evaluate the in hospital and 6 month outcomes of the use of Glycoprotein IIb/IIIa inhibitor eptifibatide as adjunctive therapy in patients undergoing primary Percutaneous Coronary Intervention for ST-elevation myocardial infarction in a large tertiary referral center.
It is hypothesized that Glycoprotein IIb/IIIa inhibitor use during primary Percutaneous Coronary Intervention for ST-elevation myocardial infarction/ acute myocardial infarction is superior to unfractionated heparin alone or bivalirudin alone. Additionally, after propensity matching this superiority remains.
Read the detailed description
This is a retrospective, observational, data analysis of approximately 800 patients who underwent primary Percutaneous Coronary Intervention at our institution since September 2000. Patients will have either received eptifibatide pre-or during Percutaneous Coronary Intervention or have received no eptifibatide. Patients who received a thrombolytic prior to Percutaneous Coronary Intervention will be excluded.
This analysis is estimated to take 1-2 months.
- Keywords
- Major adverse microvascular integrity, all cause mortality, Q Wave MI
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Eptifibatide Pre PCI | Receive eptifibatide pre PCI | |
| Eptifibatide during PCI | Receive eptifibatide during PCI | |
| No Eptifibatide | Receive no eptifibatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality and composite or Q-wave myocardial infarction
6-month rates of all-cause mortality and the composite of all-cause mortality or Q-wave myocardial infarction.
Measured: Chart review 6 months after PCI
Secondary outcomes (1)
TIMI major bleeding
Thrombolysis In Myocardial Infarction (TIMI) major bleeding during hospital stay.
Measured: During hospital stay; average stay is less than 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startOct 2013 (estimated)
- Primary completionOct 2014 (estimated)
- Study completionJun 2021
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST-elevation Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ron Waksman, MD, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01991366
- Sponsor's protocol ID
- Integrilin Stemi
- Status last verified
- Jun 2021
- First submitted
- 18 Nov 2013
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Should Integrilin be an Integral Part of Adjunctive Therapy in Patients Undergoing Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction?
- ClinicalTrials.gov ID
- NCT01991366
- Acronym / sponsor ID
- Integrilin Stemi
- Keywords
- Major adverse microvascular integrity, all cause mortality, Q Wave MI
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- Oct 2013 (estimated)
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Jun 2021 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this observational study is to evaluate the in hospital and 6 month outcomes of the use of Glycoprotein IIb/IIIa inhibitor eptifibatide as adjunctive therapy in patients undergoing primary Percutaneous Coronary Intervention for ST-elevation myocardial infarction in a large tertiary referral center.
It is hypothesized that Glycoprotein IIb/IIIa inhibitor use during primary Percutaneous Coronary Intervention for ST-elevation myocardial infarction/ acute myocardial infarction is superior to unfractionated heparin alone or bivalirudin alone. Additionally, after propensity matching this superiority remains.
Detailed description
This is a retrospective, observational, data analysis of approximately 800 patients who underwent primary Percutaneous Coronary Intervention at our institution since September 2000. Patients will have either received eptifibatide pre-or during Percutaneous Coronary Intervention or have received no eptifibatide. Patients who received a thrombolytic prior to Percutaneous Coronary Intervention will be excluded.
This analysis is estimated to take 1-2 months.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Eptifibatide Pre PCI | – | –Receive eptifibatide pre PCI |
| Eptifibatide during PCI | – | –Receive eptifibatide during PCI |
| No Eptifibatide | – | –Receive no eptifibatide |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent primary Percutaneous Coronary Intervention at Washington Hospital Center since September 2000 and received eptifibatide pre-or during PCI or have received no eptifibatide.
Key inclusion criteria (2 listed)
- Underwent Percutaneous Coronary Intervention at Washington Hospital Center since September 2000
- Either received eptifibatide pre-or during PCI or have received no eptifibatide.
Key exclusion criteria (1 listed)
- Patients who received a thrombolytic prior to Percutaneous Coronary Intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause mortality and composite or Q-wave myocardial infarction
Time frame: Chart review 6 months after PCI
6-month rates of all-cause mortality and the composite of all-cause mortality or Q-wave myocardial infarction.
1 secondary outcome
TIMI major bleeding
Time frame: During hospital stay; average stay is less than 48 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
Related trials for ST-elevation Myocardial Infarction
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
RecruitingPhase 2
Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction
Myocardial Infarction, Reperfusion Injury
Not yet recruitingObservational study
Incremental Prognostic Utility of CBC-derived Inflammatory Indices After Incomplete Coronary Revascularization: Association With 12-months Cardiovascular Outcomes
STEMI, High Risk NSTEMI
RecruitingObservational study
SuperSaturated Oxygen Comprehensive Observational Registry
STEMI - ST Elevation Myocardial Infarction, AMI
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
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.
Ron Waksman, MD principal investigator
Medstar Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ST-elevation Myocardial Infarction and Acute Myocardial Infarction, run by Medstar Health Research Institute 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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 2 Jul 2021. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
All-cause mortality and composite or Q-wave myocardial infarction (time frame: Chart review 6 months after PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2021.