Coronary Artery DiseasePhase 4PROMICRO-3NCT05643586
Effects of Ticagrelor Versus Prasugrel on Coronary Microcirculation in Patients Undergoing Elective Percutaneous Coronary Intervention: Results of the PROtecting MICROcirculation During Coronary Angioplasty (PROMICRO)-3 Randomised Study
A Phase 4 study testing Ticagrelor and Prasugrel in people with Coronary Artery Disease, run by Germano Di Sciascio at 1 site in Belgium.
Trial summary
Besides being at least as effective as prasugrel in inhibiting platelet aggregation, ticagrelor has been shown to have additional properties potentially affecting coronary microcirculation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Ticagrelor and Prasugrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Dec 2017to 14 Apr 2019
- Phase
- Phase 4
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Paitents with stable CAD referred to elective percutaneous coronary intervention (PCI) of an isolated, functionally significant (as confirmed by a fractional flow reserve [FFR] <0.80) stenosis located in the proximal two-thirds of a major coronary artery
Who cannot join
- age <18 years or ≥75 years, body weight <60 kg, previous transient ischemic attack (TIA) or stroke, acute coronary syndromes, administration of glycoprotein IIb/IIIa inhibitors, platelet count <70x109/l, high bleeding risk (active internal bleeding, history of haemorrhagic stroke, intracranial neoplasm, arteriovenous malformation or aneurysm, ischemic stroke in the previous 3 months), coronary bypass graft surgery in the previous 3 months, severe chronic renal failure (serum creatinine ≥2 mg/dl), previous myocardial infarction, left ventricular ejection fraction less than 50%, left ventricle wall-motion abnormalities, left ventricular hypertrophy, chronic total occlusion, lesions with extensive calcifications requiring rotational atherectomy, in-stent restenosis, bifurcation lesions with side branch diameter of more than 2 mm, ostial lesion, and contraindications to adenosine
Trial locations and contacts
1 site in 1 country.
About this study
Besides being at least as effective as prasugrel in inhibiting platelet aggregation, ticagrelor has been shown to have additional properties potentially affecting coronary microcirculation. We sought to compare the effects of ticagrelor and prasugrel on absolute coronary blood flow (Q) and microvascular resistance (R) in patients with stable coronary artery disease (CAD) undergoing elective percutaneous coronary intervention (PCI).
The PROMICRO-3 study shows that in patients with stable CAD undergoing PCI pre-treatment with a loading dose of ticagrelor compared with prasugrel improves post-procedural coronary flow and microvascular function and seems to reduce the related myocardial injury.
Read the detailed description
Patient population We enrolled patients naïve to platelet P2Y12 receptor inhibitors with stable CAD referred to elective percutaneous coronary intervention (PCI) of an isolated, functionally significant (as confirmed by a fractional flow reserve [FFR] <0.80) stenosis located in the proximal two-thirds of a major coronary artery.
Study protocol Patients were randomly assigned to receive loading doses of either ticagrelor (180 mg) or prasugrel (60 mg) at least 12 hours before intervention. Assignment to one of the two treatments was determined by a computer-based randomization system and randomization assignment for each patient was kept in a sealed envelope. At least 12 hours before PCI (average 13.8±1.1), a study nurse not involved in the procedure was responsible of opening the sealed envelope and administering study drugs according to treatment allocation. Both the patient and the catheterization laboratory team (operator and scrubbed nurse) were blinded to the assigned treatment. The PCI procedures were performed by standard technique. In all cases, balloon pre-dilatation was performed before stent implantation.
Adjunctive medications All patients were administered a 500-mg loading dose of aspirin the day before the procedure. In the catheterization laboratory, all patients received a weight-adjusted intravenous heparin bolus (100 IU/kg) in order to maintain activated clotting time between 250 and 300 seconds. Patients randomized to the prasugrel group received clopidogrel 75 mg once daily as of the day after the PCI, whereas patients randomized to the ticagrelor group received a 600-mg loading dose the day after PCI, and a 75-mg maintenance dose as of the next day.8
Coronary physiology indexes Coronary physiology indexes were measured in each patient before and after PCI. Briefly, an intracoronary pressure/temperature sensor-tipped guide wire (PressureWire X, Abbott, IL) was advanced through the guiding catheter in the distal segment of the target coronary artery. A dedicated monorail catheter (RayFlow, Hexacath, Paris, France), allowing the infusion of saline through 4 outer side holes and the measurement of temperature by the guidewire through 2 inner side holes, was then advanced over the guidewire. The tip of the infusion catheter was placed in the first centimeter of the coronary artery, and the catheter was connected to an infusion pump (Medrad Stellant; Medrad Inc, Warrendale, PA), and saline at room temperature infused at a pre-specified flow rate (Qi, 20 mL/min for the left anterior descending [LAD] and left circumflex artery [LCx] and 15 mL/min for the right coronary artery [RCA]), resulting in a hyperaemic state similar to that produced by adenosine. The temperature of the saline/blood mixture (T) and the distal coronary pressure (Pd) were measured after achieving a steady state. Aortic pressure (Pa) was measured through the guiding catheter. Fractional flow reserve (FFR) was calculated as Pd/Pa during hyperaemia. The temperature of the infused saline (Ti) was measured after pulling the temperature sensor of the guidewire back into the infusion catheter. Pressure tracings and temperatures were simultaneously analysed by a dedicated console equipped with software that automatically calculates physiology indexes (Coroventis Coroflow, Uppsala, Sweden). Q was calculated as 1.08 x (Ti/T) x Qi, and expressed in ml/min. Following the Ohm's law, R was calculated as Pd/Q, and expressed as mm Hg/L/min, or Wood units.
Platelet function analysis Platelet reactivity was measured before study drug assignment and at the time of PCI using the VerifyNow P2Y12 assay (Accumetrics, San Diego, California). The VerifyNow P2Y12 assay is a validated optical turbidimetric point-of-care assay specifically assessing the effects of P2Y12 receptor inhibitors:12 the results are reported as P2Y12 reaction units (PRU), and the lower the PRU value, the higher the platelet aggregation inhibition.
Peri-procedural myocardial injury High sensitivity Troponin I (hs-TnI; Roche Diagnostics, Mannheim, Germany) was determined in blood samples taken before, 8 and 24 hours after the intervention. Peak post-PCI hs-TnI levels were considered for the analysis.
Statistical analysis At the time the study was conceived, no published data were available on this topic. However, an estimate of Q values was assumed from preliminary data collected at our Institution.10 Expecting a 20% reduction in post-PCI R with ticagrelor compared with prasugrel (320±75 vs 400±85 mmHg/l/min), a total of at least 23 patients per group were needed to achieve 90% power at a 2-sided alpha of 0.05 to detect the anticipated difference. Therefore, we aimed at enrolling a total of 50 patients (25 per group). Continuous variables are expressed as mean ± SD or as median [25th, 75th percentile], as appropriate. Categorical variables are reported as frequencies and percentages. Normal distribution was tested with the Shapiro-Wilk W test. Comparisons between continuous variables were performed using the Student t test or Mann-Whitney test. These tests were corrected for repeated measures where appropriate. Repeated measures 2-way analysis of variance (ANOVA) was used to assess the effect interaction between treatment and time on continuous variables. Comparisons between categorical variables were evaluated using the Fisher exact test or the Pearson chi-square test, as appropriate. Correlations between continuous variables were assessed using the Spearman correlation test. Statistical analysis was performed using STATA/IC 14 (STATA Corp., College Station, Texas) and p values <0.05 (two tailed) were considered significant.
- Conditions
- Coronary Artery Disease
- Being tested
- Ticagrelor, Prasugrel
- Keywords
- Coronary Flow, Coronary Resistances, Platelet Reactivity
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicagrelorDrug
Also called Ticagrelor 180 mg
Patient treated with 180 mg ticagrelor 12 hours before the procedure
PrasugrelDrug
Also called Pasugrel 60 mg
Patient treated with 60 mg prasugrel 12 hours before the procedure
| Study group | Role | What they receive |
|---|---|---|
| Prasugrel Group | Experimental | Patient treated with 60 mg prasugrel 12 hours before the procedure Receives: Drug: Prasugrel |
| Ticagrelor | Experimental | Patient treated with 180 mg ticagrelor 12 hours before the procedure Receives: Drug: Ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post PCI coronary flow
Post PCI flow measured according to continous termodiluition
Measured: Immediately after the procedure
Post PCI coronary resistance
Post PCI coronary resistance measured according to continous termodiluition
Measured: Immediately after the procedure
Secondary outcomes (1)
Periprocedural myocardial injury
cTn elevation following PCI
Measured: 8 and 24 hours following the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start1 Dec 2017
- Primary completion14 Apr 2019
- Study completion14 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were randomly assigned to receive loading doses of either ticagrelor (180 mg) or prasugrel (60 mg) at least 12 hours before intervention. Assignment to one of the two treatments was determined by a computer-based randomization system.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Germano Di Sciascio
- Sponsor type
- University, hospital or other
- Collaborators
- Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium, Department of Advanced Biomedical Sciences, University of Naples Federico II, Italy, CardioRISC, C-TRIC, Derry/Londonderry, Northern Ireland, UK, University of Lausanne Hospitals
- Responsible party
- Sponsor-investigator, Germano Di Sciascio, Campus Bio-Medico University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643586
- Sponsor's protocol ID
- 2017/010
- Acronym
- PROMICRO-3
- Status last verified
- Nov 2022
- First submitted
- 30 Nov 2022
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Available following reasonable request
Publications
Mangiacapra F, Peace AJ, Di Serafino L, Pyxaras SA, Bartunek J, Wyffels E, Heyndrickx GR, Wijns W, De Bruyne B, Barbato E. Intracoronary EnalaPrilat to Reduce MICROvascular Damage During Percutaneous Coronary Intervention (ProMicro) study. J Am Coll Cardiol. 2013 Feb 12;61(6):615-21. doi: 10.1016/j.jacc.2012.11.025. Epub 2013 Jan 2.
PubMed 23290547Mangiacapra F, Di Gioia G, Pellicano M, Di Serafino L, Bressi E, Peace AJ, Bartunek J, Wijns W, De Bruyne B, Barbato E. Effects of Prasugrel Versus Clopidogrel on Coronary Microvascular Function in Patients Undergoing Elective PCI. J Am Coll Cardiol. 2016 Jul 12;68(2):235-7. doi: 10.1016/j.jacc.2016.04.039. No abstract available.
PubMed 27386781Cattaneo M, Schulz R, Nylander S. Adenosine-mediated effects of ticagrelor: evidence and potential clinical relevance. J Am Coll Cardiol. 2014 Jun 17;63(23):2503-2509. doi: 10.1016/j.jacc.2014.03.031. Epub 2014 Apr 23.
PubMed 24768873Jaffe R, Dick A, Strauss BH. Prevention and treatment of microvascular obstruction-related myocardial injury and coronary no-reflow following percutaneous coronary intervention: a systematic approach. JACC Cardiovasc Interv. 2010 Jul;3(7):695-704. doi: 10.1016/j.jcin.2010.05.004.
PubMed 20650430Xaplanteris P, Fournier S, Keulards DCJ, Adjedj J, Ciccarelli G, Milkas A, Pellicano M, Van't Veer M, Barbato E, Pijls NHJ, De Bruyne B. Catheter-Based Measurements of Absolute Coronary Blood Flow and Microvascular Resistance: Feasibility, Safety, and Reproducibility in Humans. Circ Cardiovasc Interv. 2018 Mar;11(3):e006194. doi: 10.1161/CIRCINTERVENTIONS.117.006194.
PubMed 29870386Gallinoro E, Candreva A, Colaiori I, Kodeboina M, Fournier S, Nelis O, Di Gioia G, Sonck J, van 't Veer M, Pijls NHJ, Collet C, De Bruyne B. Thermodilution-derived volumetric resting coronary blood flow measurement in humans. EuroIntervention. 2021 Oct 1;17(8):e672-e679. doi: 10.4244/EIJ-D-20-01092.
PubMed 33528358Mangiacapra F, Barbato E, Patti G, Gatto L, Vizzi V, Ricottini E, D'Ambrosio A, Wijns W, Di Sciascio G. Point-of-care assessment of platelet reactivity after clopidogrel to predict myonecrosis in patients undergoing percutaneous coronary intervention. JACC Cardiovasc Interv. 2010 Mar;3(3):318-23. doi: 10.1016/j.jcin.2009.12.012.
PubMed 20298992Mangiacapra F, Colaiori I, Di Gioia G, Pellicano M, Heyse A, Paolucci L, Peace A, Bartunek J, de Bruyne B, Barbato E. Effects of ticagrelor and prasugrel on coronary microcirculation in elective percutaneous coronary intervention. Heart. 2023 Dec 20;110(2):115-121. doi: 10.1136/heartjnl-2022-321868.
PubMed 37316163
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ticagrelor Versus Prasugrel on Coronary Microcirculation in Patients Undergoing Elective Percutaneous Coronary Intervention: Results of the PROtecting MICROcirculation During Coronary Angioplasty (PROMICRO)-3 Randomised Study
- ClinicalTrials.gov ID
- NCT05643586
- Acronym / sponsor ID
- PROMICRO-3 / 2017/010
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Flow, Coronary Resistances, Platelet Reactivity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Germano Di SciascioUniversity, hospital or other
- Collaborators
- Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium, Department of Advanced Biomedical Sciences, University of Naples Federico II, Italy, CardioRISC, C-TRIC, Derry/Londonderry, Northern Ireland, UK, University of Lausanne Hospitals
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 14 Apr 2019 (actual)
- Study completion
- 14 Apr 2019 (actual)
- First posted
- 8 Dec 2022 (actual)
- 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.
Besides being at least as effective as prasugrel in inhibiting platelet aggregation, ticagrelor has been shown to have additional properties potentially affecting coronary microcirculation. We sought to compare the effects of ticagrelor and prasugrel on absolute coronary blood flow (Q) and microvascular resistance (R) in patients with stable coronary artery disease (CAD) undergoing elective percutaneous coronary intervention (PCI).
The PROMICRO-3 study shows that in patients with stable CAD undergoing PCI pre-treatment with a loading dose of ticagrelor compared with prasugrel improves post-procedural coronary flow and microvascular function and seems to reduce the related myocardial injury.
Detailed description
Patient population We enrolled patients naïve to platelet P2Y12 receptor inhibitors with stable CAD referred to elective percutaneous coronary intervention (PCI) of an isolated, functionally significant (as confirmed by a fractional flow reserve [FFR] <0.80) stenosis located in the proximal two-thirds of a major coronary artery.
Study protocol Patients were randomly assigned to receive loading doses of either ticagrelor (180 mg) or prasugrel (60 mg) at least 12 hours before intervention. Assignment to one of the two treatments was determined by a computer-based randomization system and randomization assignment for each patient was kept in a sealed envelope. At least 12 hours before PCI (average 13.8±1.1), a study nurse not involved in the procedure was responsible of opening the sealed envelope and administering study drugs according to treatment allocation. Both the patient and the catheterization laboratory team (operator and scrubbed nurse) were blinded to the assigned treatment. The PCI procedures were performed by standard technique. In all cases, balloon pre-dilatation was performed before stent implantation.
Adjunctive medications All patients were administered a 500-mg loading dose of aspirin the day before the procedure. In the catheterization laboratory, all patients received a weight-adjusted intravenous heparin bolus (100 IU/kg) in order to maintain activated clotting time between 250 and 300 seconds. Patients randomized to the prasugrel group received clopidogrel 75 mg once daily as of the day after the PCI, whereas patients randomized to the ticagrelor group received a 600-mg loading dose the day after PCI, and a 75-mg maintenance dose as of the next day.8
Coronary physiology indexes Coronary physiology indexes were measured in each patient before and after PCI. Briefly, an intracoronary pressure/temperature sensor-tipped guide wire (PressureWire X, Abbott, IL) was advanced through the guiding catheter in the distal segment of the target coronary artery. A dedicated monorail catheter (RayFlow, Hexacath, Paris, France), allowing the infusion of saline through 4 outer side holes and the measurement of temperature by the guidewire through 2 inner side holes, was then advanced over the guidewire. The tip of the infusion catheter was placed in the first centimeter of the coronary artery, and the catheter was connected to an infusion pump (Medrad Stellant; Medrad Inc, Warrendale, PA), and saline at room temperature infused at a pre-specified flow rate (Qi, 20 mL/min for the left anterior descending [LAD] and left circumflex artery [LCx] and 15 mL/min for the right coronary artery [RCA]), resulting in a hyperaemic state similar to that produced by adenosine. The temperature of the saline/blood mixture (T) and the distal coronary pressure (Pd) were measured after achieving a steady state. Aortic pressure (Pa) was measured through the guiding catheter. Fractional flow reserve (FFR) was calculated as Pd/Pa during hyperaemia. The temperature of the infused saline (Ti) was measured after pulling the temperature sensor of the guidewire back into the infusion catheter. Pressure tracings and temperatures were simultaneously analysed by a dedicated console equipped with software that automatically calculates physiology indexes (Coroventis Coroflow, Uppsala, Sweden). Q was calculated as 1.08 x (Ti/T) x Qi, and expressed in ml/min. Following the Ohm's law, R was calculated as Pd/Q, and expressed as mm Hg/L/min, or Wood units.
Platelet function analysis Platelet reactivity was measured before study drug assignment and at the time of PCI using the VerifyNow P2Y12 assay (Accumetrics, San Diego, California). The VerifyNow P2Y12 assay is a validated optical turbidimetric point-of-care assay specifically assessing the effects of P2Y12 receptor inhibitors:12 the results are reported as P2Y12 reaction units (PRU), and the lower the PRU value, the higher the platelet aggregation inhibition.
Peri-procedural myocardial injury High sensitivity Troponin I (hs-TnI; Roche Diagnostics, Mannheim, Germany) was determined in blood samples taken before, 8 and 24 hours after the intervention. Peak post-PCI hs-TnI levels were considered for the analysis.
Statistical analysis At the time the study was conceived, no published data were available on this topic. However, an estimate of Q values was assumed from preliminary data collected at our Institution.10 Expecting a 20% reduction in post-PCI R with ticagrelor compared with prasugrel (320±75 vs 400±85 mmHg/l/min), a total of at least 23 patients per group were needed to achieve 90% power at a 2-sided alpha of 0.05 to detect the anticipated difference. Therefore, we aimed at enrolling a total of 50 patients (25 per group). Continuous variables are expressed as mean ± SD or as median [25th, 75th percentile], as appropriate. Categorical variables are reported as frequencies and percentages. Normal distribution was tested with the Shapiro-Wilk W test. Comparisons between continuous variables were performed using the Student t test or Mann-Whitney test. These tests were corrected for repeated measures where appropriate. Repeated measures 2-way analysis of variance (ANOVA) was used to assess the effect interaction between treatment and time on continuous variables. Comparisons between categorical variables were evaluated using the Fisher exact test or the Pearson chi-square test, as appropriate. Correlations between continuous variables were assessed using the Spearman correlation test. Statistical analysis was performed using STATA/IC 14 (STATA Corp., College Station, Texas) and p values <0.05 (two tailed) were considered significant.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients were randomly assigned to receive loading doses of either ticagrelor (180 mg) or prasugrel (60 mg) at least 12 hours before intervention. Assignment to one of the two treatments was determined by a computer-based randomization system.
| Arm | Type | Receives |
|---|---|---|
| Prasugrel Group | Experimental | Drug: PrasugrelPatient treated with 60 mg prasugrel 12 hours before the procedure |
| Ticagrelor | Experimental | Drug: TicagrelorPatient treated with 180 mg ticagrelor 12 hours before the procedure |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Paitents with stable CAD referred to elective percutaneous coronary intervention (PCI) of an isolated, functionally significant (as confirmed by a fractional flow reserve [FFR] <0.80) stenosis located in the proximal two-thirds of a major coronary artery
Key exclusion criteria (1 listed)
- age <18 years or ≥75 years, body weight <60 kg, previous transient ischemic attack (TIA) or stroke, acute coronary syndromes, administration of glycoprotein IIb/IIIa inhibitors, platelet count <70x109/l, high bleeding risk (active internal bleeding, history of haemorrhagic stroke, intracranial neoplasm, arteriovenous malformation or aneurysm, ischemic stroke in the previous 3 months), coronary bypass graft surgery in the previous 3 months, severe chronic renal failure (serum creatinine ≥2 mg/dl), previous myocardial infarction, left ventricular ejection fraction less than 50%, left ventricle wall-motion abnormalities, left ventricular hypertrophy, chronic total occlusion, lesions with extensive calcifications requiring rotational atherectomy, in-stent restenosis, bifurcation lesions with side branch diameter of more than 2 mm, ostial lesion, and contraindications to adenosine
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 |
|---|---|---|
| TicagrelorAlso: Ticagrelor 180 mgPatient treated with 180 mg ticagrelor 12 hours before the procedure | Drug | Ticagrelor |
| PrasugrelAlso: Pasugrel 60 mgPatient treated with 60 mg prasugrel 12 hours before the procedure | Drug | Prasugrel Group |
Primary outcome
Post PCI coronary flow
Time frame: Immediately after the procedure
Post PCI flow measured according to continous termodiluition
Post PCI coronary resistance
Time frame: Immediately after the procedure
Post PCI coronary resistance measured according to continous termodiluition
1 secondary outcome
Periprocedural myocardial injury
Time frame: 8 and 24 hours following the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
- Background: PubMed 23290547Mangiacapra F, Peace AJ, Di Serafino L, Pyxaras SA, Bartunek J, Wyffels E, Heyndrickx GR, Wijns W, De Bruyne B, Barbato E. Intracoronary EnalaPrilat to Reduce MICROvascular Damage During Percutaneous Coronary Intervention (ProMicro) study. J Am Coll Cardiol. 2013 Feb 12;61(6):615-21. doi: 10.1016/j.jacc.2012.11.025. Epub 2013 Jan 2.
- Background: PubMed 27386781Mangiacapra F, Di Gioia G, Pellicano M, Di Serafino L, Bressi E, Peace AJ, Bartunek J, Wijns W, De Bruyne B, Barbato E. Effects of Prasugrel Versus Clopidogrel on Coronary Microvascular Function in Patients Undergoing Elective PCI. J Am Coll Cardiol. 2016 Jul 12;68(2):235-7. doi: 10.1016/j.jacc.2016.04.039. No abstract available.
- Background: PubMed 24768873Cattaneo M, Schulz R, Nylander S. Adenosine-mediated effects of ticagrelor: evidence and potential clinical relevance. J Am Coll Cardiol. 2014 Jun 17;63(23):2503-2509. doi: 10.1016/j.jacc.2014.03.031. Epub 2014 Apr 23.
- Background: PubMed 20650430Jaffe R, Dick A, Strauss BH. Prevention and treatment of microvascular obstruction-related myocardial injury and coronary no-reflow following percutaneous coronary intervention: a systematic approach. JACC Cardiovasc Interv. 2010 Jul;3(7):695-704. doi: 10.1016/j.jcin.2010.05.004.
- Background: PubMed 29870386Xaplanteris P, Fournier S, Keulards DCJ, Adjedj J, Ciccarelli G, Milkas A, Pellicano M, Van't Veer M, Barbato E, Pijls NHJ, De Bruyne B. Catheter-Based Measurements of Absolute Coronary Blood Flow and Microvascular Resistance: Feasibility, Safety, and Reproducibility in Humans. Circ Cardiovasc Interv. 2018 Mar;11(3):e006194. doi: 10.1161/CIRCINTERVENTIONS.117.006194.
- Background: PubMed 33528358Gallinoro E, Candreva A, Colaiori I, Kodeboina M, Fournier S, Nelis O, Di Gioia G, Sonck J, van 't Veer M, Pijls NHJ, Collet C, De Bruyne B. Thermodilution-derived volumetric resting coronary blood flow measurement in humans. EuroIntervention. 2021 Oct 1;17(8):e672-e679. doi: 10.4244/EIJ-D-20-01092.
- Background: PubMed 20298992Mangiacapra F, Barbato E, Patti G, Gatto L, Vizzi V, Ricottini E, D'Ambrosio A, Wijns W, Di Sciascio G. Point-of-care assessment of platelet reactivity after clopidogrel to predict myonecrosis in patients undergoing percutaneous coronary intervention. JACC Cardiovasc Interv. 2010 Mar;3(3):318-23. doi: 10.1016/j.jcin.2009.12.012.
- Derived from this study: PubMed 37316163Mangiacapra F, Colaiori I, Di Gioia G, Pellicano M, Heyse A, Paolucci L, Peace A, Bartunek J, de Bruyne B, Barbato E. Effects of ticagrelor and prasugrel on coronary microcirculation in elective percutaneous coronary intervention. Heart. 2023 Dec 20;110(2):115-121. doi: 10.1136/heartjnl-2022-321868.
- Individual participant dataSharing planned: Yes. Available following reasonable request
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ticagrelor and Prasugrel in people with Coronary Artery Disease, run by Germano Di Sciascio at 1 site in Belgium.
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 1 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: finished, as of the sponsor's last update on 8 Dec 2022. 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 Belgium. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Post PCI coronary flow (time frame: Immediately after the procedure). 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 NCT05643586, which also lists 8 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 8 Dec 2022.