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With potent analgesic properties, perceived hemodynamic benefits and limited alternatives, opiates are the analgesic mainstay for acute coronary syndrome (ACS) patients reporting peri-procedural pain or nitrate-resistant chest pain. However, large observational studies suggest that opiate administration during ACS may result in adverse cardiovascular outcomes. Complimenting this, a number of recent mechanistic studies have demonstrated delayed and attenuated effects of oral dual anti-platelet therapy (DAPT) on platelet inhibition endpoints among subjects receiving intravenous morphine. These studies support the hypothesis that morphine delays the gastrointestinal absorption of DAPT medications. However, no data exist on the impact of intravenous fentanyl, a systemic opioid analgesic routinely administered during percutaneous coronary intervention (PCI) procedures, on the platelet inhibition effects of DAPT. The investigators hypothesize that, similar to morphine, fentanyl administered at the time of PCI will reduce and delay the effect of DAPT on platelet function. As such, the primary aim of this study is to test the impact of intravenous fentanyl on residual platelet reactivity by randomizing patients undergoing PCI to a strategy of peri-procedural benzodiazepine plus non-systemic local analgesia or to the current standard of benzodiazepine plus intravenous fentanyl. Given the critical need for rapid and robust inhibition of platelet function during PCI, this trial has true potential to change clinical practice, particularly if the investigators demonstrate reduced DAPT absorption and elevated residual platelet reactivity among patients receiving fentanyl during PCI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCI without IV opiate | Experimental | IV midazolam and Local Anesthetic, with removal of IV fentanyl from peri-procedural analgesia (which is otherwise routinely given) |
|
| PCI with IV opiate | Active Comparator | IV midazolam and Local Anesthetic and IV fentanyl for peri-procedural analgesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Removal of Fentanyl from peri-procedural analgesia | Other | Removal of Fentanyl from peri-procedural analgesia (which is otherwise routinely given for PCI) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ticagrelor Pharmacokinetics | Area under the curve for Ticagrelor Absorption | Measured over 24 hours (at 0, 0.5, 1, 2, 4, and 24 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Single Time-point Platelet Reactivity Using Verify Now | Blood test of Platelet Cell Reactivity using Verify Now (P2Y12 Reactivity Units) | Measured at 2 hours |
| Platelet Reactivity Using Light Transmission Aggregometry |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John W McEvoy, MBBCh MHS | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital and University School of Medicicine | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29972861 | Derived | Ibrahim K, Shah R, Goli RR, Kickler TS, Clarke WA, Hasan RK, Blumenthal RS, Thiemann DR, Resar JR, Schulman SP, McEvoy JW. Fentanyl Delays the Platelet Inhibition Effects of Oral Ticagrelor: Full Report of the PACIFY Randomized Clinical Trial. Thromb Haemost. 2018 Aug;118(8):1409-1418. doi: 10.1055/s-0038-1666862. Epub 2018 Jul 4. | |
| 29170073 |
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| ID | Title | Description |
|---|---|---|
| FG000 | PCI Without Intranvenous (IV) Opiate | IV midazolam and Local Anesthetic, with removal of IV fentanyl from peri-procedural analgesia (which is otherwise routinely given) Removal of Fentanyl from peri-procedural analgesia: Removal of Fentanyl from peri-procedural analgesia (which is otherwise routinely given for percutaneous coronary intervention [PCI]) Lidocaine: Local Anesthetic Midazolam: IV sedation |
| FG001 | PCI With IV Opiate | IV midazolam and Local Anesthetic and IV fentanyl for peri-procedural analgesia Fentanyl: IV peri-procedural analgesia Lidocaine: Local Anesthetic Midazolam: IV sedation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PCI Without IV Opiate | IV midazolam and Local Anesthetic, with removal of IV fentanyl from peri-procedural analgesia (which is otherwise routinely given) Removal of Fentanyl from peri-procedural analgesia: Removal of Fentanyl from peri-procedural analgesia (which is otherwise routinely given for PCI) Lidocaine: Local Anesthetic Midazolam: IV sedation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ticagrelor Pharmacokinetics | Area under the curve for Ticagrelor Absorption | Only the subgroup (n=70) of enrolled participants who required PCI and were loaded with ticagrelor had information on the primary endpoint | Posted | Mean | Standard Error | ng*hr/mL | Measured over 24 hours (at 0, 0.5, 1, 2, 4, and 24 hours) |
|
Adverse event data (specifically pain and anxiety reports from participants) were collected on the day of the procedure during which each participant was under study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PCI Without IV Opiate | IV midazolam and Local Anesthetic, with removal of IV fentanyl from peri-procedural analgesia (which is otherwise routinely given) Removal of Fentanyl from peri-procedural analgesia: Removal of Fentanyl from peri-procedural analgesia (which is otherwise routinely given for PCI) Lidocaine: Local Anesthetic Midazolam: IV sedation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain >5/10 | General disorders | Systematic Assessment |
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Small sample, surrogate endpoints
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr J William McEvoy | JohnsHopkinsU | 4109555000 | jmcevoy1@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 20, 2016 | Apr 5, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D008012 | Lidocaine |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000083 | Acetanilides |
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| Fentanyl | Drug | IV peri-procedural analgesia |
|
| Lidocaine | Drug | Local Anesthetic |
|
| Midazolam | Drug | IV sedation |
|
Blood test of Platelet Cell Reactivity using Light Transmission Aggregometry (reported as percent of baseline aggregation in response to adenosine diphosphate stimulation)
| Measured at 2 hours |
| Patient Self-reported Pain | Patient self report of pain using a visual analog scale (VAS). Scale ranges from 0 to 10 with 0 being "No pain" and 10 being "Most severe pain". | 2 hours |
| Ibrahim K, Goli RR, Shah R, Resar JR, Schulman SP, McEvoy JW. Effect of intravenous fentanyl on ticagrelor absorption and platelet inhibition among patients undergoing percutaneous coronary intervention: Design, rationale, and sample characteristics of the PACIFY randomized trial. Contemp Clin Trials. 2018 Jan;64:8-12. doi: 10.1016/j.cct.2017.11.011. Epub 2017 Nov 21. |
| 29046319 | Derived | McEvoy JW, Ibrahim K, Kickler TS, Clarke WA, Hasan RK, Czarny MJ, Keramati AR, Goli RR, Gratton TP, Brinker JA, Chacko M, Hwang CW, Johnston PV, Miller JM, Trost JC, Herzog WR, Blumenthal RS, Thiemann DR, Resar JR, Schulman SP. Effect of Intravenous Fentanyl on Ticagrelor Absorption and Platelet Inhibition Among Patients Undergoing Percutaneous Coronary Intervention: The PACIFY Randomized Clinical Trial (Platelet Aggregation With Ticagrelor Inhibition and Fentanyl). Circulation. 2018 Jan 16;137(3):307-309. doi: 10.1161/CIRCULATIONAHA.117.031678. Epub 2017 Oct 18. No abstract available. |
| BG001 |
| PCI With IV Opiate |
IV midazolam and Local Anesthetic and IV fentanyl for peri-procedural analgesia Fentanyl: IV peri-procedural analgesia Lidocaine: Local Anesthetic Midazolam: IV sedation |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Platelet count | Mean | Standard Deviation | K/cu mm |
|
IV midazolam and Local Anesthetic and IV fentanyl for peri-procedural analgesia Fentanyl: IV peri-procedural analgesia Lidocaine: Local Anesthetic Midazolam: IV sedation |
|
|
| Secondary | Single Time-point Platelet Reactivity Using Verify Now | Blood test of Platelet Cell Reactivity using Verify Now (P2Y12 Reactivity Units) | Only the subgroup (n=70) of enrolled participants who required PCI and were loaded with ticagrelor had information on the primary endpoint | Posted | Mean | Standard Deviation | PRUs | Measured at 2 hours |
|
|
|
| Secondary | Platelet Reactivity Using Light Transmission Aggregometry | Blood test of Platelet Cell Reactivity using Light Transmission Aggregometry (reported as percent of baseline aggregation in response to adenosine diphosphate stimulation) | Only the subgroup (n=70) of enrolled participants who required PCI and were loaded with ticagrelor had information on the primary endpoint | Posted | Mean | Standard Deviation | percentage of baseline aggregation | Measured at 2 hours |
|
|
|
| Secondary | Patient Self-reported Pain | Patient self report of pain using a visual analog scale (VAS). Scale ranges from 0 to 10 with 0 being "No pain" and 10 being "Most severe pain". | Posted | Mean | Standard Deviation | units on a scale | 2 hours |
|
|
|
| 0 |
| 105 |
| 13 |
| 105 |
| 0 |
| 105 |
| EG001 | PCI With IV Opiate | IV midazolam and Local Anesthetic and IV fentanyl for peri-procedural analgesia Fentanyl: IV peri-procedural analgesia Lidocaine: Local Anesthetic Midazolam: IV sedation | 0 | 107 | 7 | 107 | 0 | 107 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D000813 |
| Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |