Non-ST Elevation Myocardial Infarction (NSTEMI)NCT03048019
Antiplatelet Effects of Tirofiban vs. Cangrelor N-STEMI Patients Undergoing Percutaneous Coronary Intervention
An observational study of Non-ST Elevation Myocardial Infarction (NSTEMI), run by Inova Health Care Services at 1 site in United States.
Trial summary
Immediate potent inhibition of platelet function is critical for the prevention of periprocedural ischemic event occurrences in high risk N-ST segment elevation myocardial infarction (NSTEMI) in patients undergoing percutaneous coronary intervention (PCI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-ST Elevation Myocardial Infarction (NSTEMI)
- What is being tested?
- Tirofiban and Cangrelor
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2017to 27 Jun 2019
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: This study will consist of NSTEMI patients undergoing percutaneous coronary intervention (PCI): 30 patients each will be treated with tirofiban or cangrelor (total n=60).
Who may be able to join
- 1. NSTEMI meeting the following criteria:
- Patients 18 years of age or older with one or more of the following symptoms:
- new ST-segment depression or transient elevation of at least 1 mm
- elevations in troponin I, troponin T, or creatine kinase MB levels above ULN
- Eligible for ticagrelor, cangrelor, aspirin, UFH, and GP IIb/IIIa inhibitor treatment.
- Admitted at cardiac catheterization laboratory hospital or associated facility.
- Competent mental condition to provide informed consent.
Who cannot join
- Unstable angina, STEMI
- Cardiogenic shock
- Refractory ventricular arrhythmias
- New York Heart Association class IV congestive heart failure
- Cardiac arrest within 1 week of study entry
- History of hemorrhagic or ischemic stroke, TIA, sub-arachnoid hemorrhage or intracranial neoplasm, arteriovenous malformation, or aneurysm
Show all 22Show fewer
- Fibrinolytic therapy within 48 hours of study entry
- Active pathological bleeding or history of bleeding diathesis
- Severe hepatic insufficiency
- Current peptic ulceration
- Increased bleeding risk, per investigator judgment
- Known anemia (hematocrit<25%)/thrombocytopenia (platelet count < 100,000mm3)
- Surgery within 4 weeks before study entry or planned surgery within 2 months after study entry
- Any P2Y12 receptor inhibitor or GP IIb/IIIa inhibitor within 7 days of study entry
- Receiving warfarin or other coumadin derivatives or NOACs within the last 10 days with an INR >1.5 secs or planned use during the hospitalization period
- Contraindication to the use of ticagrelor and/or aspirin
- Receiving or will receive oral anticoagulation or other oral antiplatelet therapy (except aspirin) that cannot be safely discontinued within the next 3 months
- Receiving daily NSAIDs or COX2 inhibitors that cannot be discontinued or anticipated to require >2 weeks of daily NSAIDs or COX2 inhibitors during study
- Investigational drug in last 30 days or presently enrolled in drug/device study
- Women of childbearing potential (post-menopausal women can be enrolled if at least 1 year of amenorrhea or surgically sterile)
- Condition associated with poor treatment compliance (e.g., alcoholism, mental illness, or drug dependence)
- Inability to provide written informed consent and to understand the full meaning of the informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Inova Health Care System
Falls Church, Virginia, 22042
About this study
Official title: Comparison of Pharmacodynamic Effects of Tirofiban vs. Cangrelor in N-STEMI Patients Undergoing Percutaneous Coronary Intervention
Immediate potent inhibition of platelet function is critical for the prevention of periprocedural ischemic event occurrences in high risk N-ST segment elevation myocardial infarction (NSTEMI) in patients undergoing percutaneous coronary intervention (PCI). Currently, dual antiplatelet therapy with aspirin and an oral P2Y12 receptor blocker (with loading doses) is widely used for PCI. However, immediate, potent and reversible inhibition of platelet aggregation is not possible even with the newer oral agents, prasugrel and ticagrelor. Therefore, an intravenously administered GPIIb/IIIa receptor inhibitor (tirofiban) or P2Y12 receptor blocker (cangrelor) with fast onset and offset of actions will provide more desired antiplatelet effects in the setting of PCI. This study will measure and compare the anti-platelet effects of Tirofiban and Cangrelor in patients presenting with N-STEMI and undergoing PCI.
- Being tested
- Tirofiban, Cangrelor
- Medical subject headings
- Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirofibanDrug
Also called Aggrastat
Patients will receive Tirofiban during the PCI procedure
CangrelorDrug
Also called Kengreal
Patients will receive Cangrelor during the PCI procedure
| Study group | Role | What they receive |
|---|---|---|
| Tirofiban Therapy | patients randomized to tirofiban therapy Receives: Drug: Tirofiban | |
| Cangrelor Therapy | patients randomized to cangrelor therapy Receives: Drug: Cangrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombin Receptor Activator Peptide (TRAP) Induced Platelet Aggregation (%)
Assessment of platelet aggregation (%) in response to 10uM thrombin receptor activator peptide. Normal reference range is 60-100% aggregation.
Measured: 30 minutes post-start of the infusion
Secondary outcomes (3)
Adenosine Diphosphate (ADP) Induced Platelet Aggregation (%)
Assessment of platelet aggregation (%) in response to 20uM ADP at baseline and serially following tirofiban or cangrelor infusion. Normal reference range is 60-100% aggregation.
Measured: 30 minutes post-start of the infusion
Thrombin Induced Platelet-fibrin Clot Strength (mm)
Assessment of thrombin induced platelet-fibrin clot strength (mm) by thromboelastography (TEG6S). Normal reference range is 55-68 mm
Measured: 30 minutes post-start of the infusion
Shear-induced Thrombus Formation (AUC)
Real time evaluation of shear-induced thrombus formation using novel RUO T-TAS plus system. AUC is calculated as time to reach 60 kPa
Measured: 30 minutes after the end of the infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start23 Aug 2017
- Primary completion27 Jun 2019
- Study completion27 Jun 2019
Why it stopped: study terminated per PI
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.
- Other trials for Non-ST Elevation Myocardial Infarction (NSTEMI)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Gurbel, MD, Principal investigator, Inova Health Care Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048019
- Sponsor's protocol ID
- 17-2617
- Status last verified
- Dec 2023
- First submitted
- 7 Feb 2017
- Last updated
- 11 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pharmacodynamic Effects of Tirofiban vs. Cangrelor in N-STEMI Patients Undergoing Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT03048019
- Acronym / sponsor ID
- 17-2617
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: study terminated per PI
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Study start
- 23 Aug 2017 (actual)
- Primary completion
- 27 Jun 2019 (actual)
- Study completion
- 27 Jun 2019 (actual)
- First posted
- 9 Feb 2017 (estimated)
- Results
- Posted 11 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Immediate potent inhibition of platelet function is critical for the prevention of periprocedural ischemic event occurrences in high risk N-ST segment elevation myocardial infarction (NSTEMI) in patients undergoing percutaneous coronary intervention (PCI). Currently, dual antiplatelet therapy with aspirin and an oral P2Y12 receptor blocker (with loading doses) is widely used for PCI. However, immediate, potent and reversible inhibition of platelet aggregation is not possible even with the newer oral agents, prasugrel and ticagrelor. Therefore, an intravenously administered GPIIb/IIIa receptor inhibitor (tirofiban) or P2Y12 receptor blocker (cangrelor) with fast onset and offset of actions will provide more desired antiplatelet effects in the setting of PCI. This study will measure and compare the anti-platelet effects of Tirofiban and Cangrelor in patients presenting with N-STEMI and undergoing PCI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tirofiban Therapy | – | Drug: Tirofibanpatients randomized to tirofiban therapy |
| Cangrelor Therapy | – | Drug: Cangrelorpatients randomized to cangrelor therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will consist of NSTEMI patients undergoing percutaneous coronary intervention (PCI): 30 patients each will be treated with tirofiban or cangrelor (total n=60).
Key inclusion criteria (7 listed)
- Patients 18 years of age or older with one or more of the following symptoms:
- Eligible for ticagrelor, cangrelor, aspirin, UFH, and GP IIb/IIIa inhibitor treatment.
- Admitted at cardiac catheterization laboratory hospital or associated facility.
- Competent mental condition to provide informed consent.
Key exclusion criteria (22 listed)
- Unstable angina, STEMI
- Cardiogenic shock
- Refractory ventricular arrhythmias
- New York Heart Association class IV congestive heart failure
- Cardiac arrest within 1 week of study entry
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 |
|---|---|---|
| TirofibanAlso: AggrastatPatients will receive Tirofiban during the PCI procedure | Drug | Tirofiban Therapy |
| CangrelorAlso: KengrealPatients will receive Cangrelor during the PCI procedure | Drug | Cangrelor Therapy |
Primary outcome
Thrombin Receptor Activator Peptide (TRAP) Induced Platelet Aggregation (%)
Time frame: 30 minutes post-start of the infusion
Assessment of platelet aggregation (%) in response to 10uM thrombin receptor activator peptide. Normal reference range is 60-100% aggregation.
3 secondary outcomes
Adenosine Diphosphate (ADP) Induced Platelet Aggregation (%)
Time frame: 30 minutes post-start of the infusion
Thrombin Induced Platelet-fibrin Clot Strength (mm)
Time frame: 30 minutes post-start of the infusion
Shear-induced Thrombus Formation (AUC)
Time frame: 30 minutes after the end of the infusion.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Paul Gurbel, MD principal investigator
Inova Health Care Services
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 Non-ST Elevation Myocardial Infarction (NSTEMI), run by Inova Health Care Services 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 7 inclusion and 22 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: stopped early, as of the sponsor's last update on 11 Dec 2023. 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?
Yes. Results are posted in the registry (first posted 11 Dec 2023). 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?
Thrombin Receptor Activator Peptide (TRAP) Induced Platelet Aggregation (%) (time frame: 30 minutes post-start of the infusion). 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 11 Dec 2023.