PRotective Effect on the Coronary Microcirculation of Patients With DIabetes by Clopidogrel or Ticagrelor
PREDICT
2 other identifiers
interventional
50
1 country
3
Brief Summary
The purpose of this study is to determine whether Ticagrelor has a protective effect on microcirculation during percutaneous coronary interventions in patients with Diabetes mellitus type II or in a pre-diabetic status.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 diabetes-mellitus-type-2
Started Mar 2016
Shorter than P25 for phase_4 diabetes-mellitus-type-2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2016
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedFirst Posted
Study publicly available on registry
March 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedMarch 4, 2016
February 1, 2016
1 year
February 11, 2016
February 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Delta IMR post-PCI
Absolute difference in the IMR value associated to PCI \["Delta IMR Post-PCI" = (IMR value post-PCI) minus (IMR value pre-PCI)\]
at least 48 hours after randomization, just after PCI and stenting.
Delta IMR pre-PCI
Absolute difference in the IMR value associated to PCI \["Delta IMR Pre-PCI" = (IMR value pre-PCI) minus (IMR value at baseline)\]
at least 48 hours after randomization, just before PCI and stenting.
Secondary Outcomes (3)
Myocardial necrosis associated to PCI damage
at least 72 hours, at the time of hospital discharge.
IMR post-PCI
at least 48 hours after randomization, just after PCI and stenting.
Severe microcirculatory impairment
at least 48 hours after randomization, just after PCI and stenting.
Other Outcomes (5)
Delta IMR post-PCI in subject with BMI = or > 30
at least 48 hours after randomization, just after PCI and stenting.
Delta IMR pre-PCI in subject with BMI = or > 30
at least 48 hours after randomization, just before PCI and stenting.
Myocardial necrosis associated to PCI damage in subject with BMI = or > 30
at least 72 hours, at the time of hospital discharge.
- +2 more other outcomes
Study Arms (2)
Ticagrelor
EXPERIMENTALA loading dose of Ticagrelor 180mg followed by a dose of 90mg b.i.d. (during 48 hours)
Clopidogrel
ACTIVE COMPARATORA loading dose of Clopidogrel 600mg followed by a daily dose (during at least 48 hours) of 75mg
Interventions
Pre-PCI and treatment: 1. At hospital admission: all consecutive patients referred for coronary angiography in stable ischemic heart disease will undergo a complete physical examination, Electrocardiogram (ECG) and laboratory blood testing including cardiac troponin and kinase mioband. Subjects will be investigated to confirm or diagnose existing diabetic or pre-diabetic status. 2. At the time of diagnostic catheterization After informed consent, diabetic or pre-diabetic patients with at least one stenosis with a Fractional Flow Reserve value (FFR) ≤ 0.80 fulfilling all the inclusion/exclusion criteria will be included in the trial.At the same time, a multimodal physiology assessment, including Coronary Flow Reserve (CFR) and Index of Microcirculatory Resistance (IMR) will be measured.
Randomization: patients will be randomly assigned (with 1:1 ratio) to receive either Clopidogrel or Ticagrelor before their clinically-indicated Percutaneous Coronary Intervention (PCI). Either a loading dose of Ticagrelor 180mg followed by a dose of 90mg b.i.d. (during 48 hours) or a loading dose of Clopidogrel 600mg followed by a daily dose (during at least 48 hours) of 75mg will be administered according to their randomization. Additionally the groups will be balanced according to obesity prevalence \[Body Mass Index (BMI) ≥30 kg/m2\] with the implementation of a dedicated randomization list.
1. Pre-PCI: multimodal physiological evaluation: FFR, CFR, IMR will be repeated 2. PCI: For all the patients undergoing PCI, the use of unfractioned heparin (UHF) will be allowed at the time of PCI; UFH be administered with a target on Activated Clotting Time (ACT) of 200-250 s. The PCI procedures will be performed by standard technique using only second generation Drug Eluting Stents (DES). In all cases, balloon pre-dilatation will be performed before stent implantation using a semi-compliant balloon with a diameter lower than a 75% of the distal reference diameter of the vessel to avoid confounders Post-dilation will be performed according to clinical practice although it will be not mandatory. 3. Post-PCI: After stent implantation/s, multimodal physiological evaluation will be re-performed (FFR, CFR, IMR).
Eligibility Criteria
You may qualify if:
- Subject with Diabetes Mellitus (DM) Type II
- Subject must be older than 18 years
- Written informed consent available
- Subject with stable ischemic heart disease referred for coronary angiography
- Subject is eligible for PCI, and PCI target(s) have FFR≤0.80
You may not qualify if:
- Prior myocardial infarction in the territory of the target vessel
- Akinesia or dyskinesia in subtended myocardial segments
- Severe impairment of left ventricular function (LVEF) \<35%
- PCI target is a chronic total occlusion
- Target lesion has been treated previously (restenotic lesions)
- Target vessel is a saphenous vein graft or a surgical graft has been anastomosed to target vessel
- Thrombolisis in Myocardial Infarction (TIMI) flow ≤ 1 prior to guide wire crossing
- Subject is not eligible for treatment with DES
- Bleeding disorders or chronic anticoagulant treatment
- Left main stenosis \> 50%
- Coronary surgery deemed more beneficial for the patient than PCI
- Intolerance or contraindications to anti-platelet drugs
- Contraindications for adenosine administration
- Platelet count \<75000 or \>700000/mm3
- Immunosuppressive therapy
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital San Carlos
Madrid, Madrid, 28040, Spain
Hospital Galdakao-Usansolo
Bilbao, Vizcaya, 48960, Spain
Related Publications (1)
Cerrato E, Quiros A, Echavarria-Pinto M, Mejia-Renteria H, Aldazabal A, Ryan N, Gonzalo N, Jimenez-Quevedo P, Nombela-Franco L, Salinas P, Nunez-Gil IJ, Rumoroso JR, Fernandez-Ortiz A, Macaya C, Escaned J. PRotective Effect on the coronary microcirculation of patients with DIabetes by Clopidogrel or Ticagrelor (PREDICT): study rationale and design. A randomized multicenter clinical trial using intracoronary multimodal physiology. Cardiovasc Diabetol. 2017 May 19;16(1):68. doi: 10.1186/s12933-017-0543-5.
PMID: 28526024DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Javier Escaned, MD, PhD
Hospital San Carlos, Madrid, Spain
- PRINCIPAL INVESTIGATOR
Enrico Cerrato, MD
San Luigi Gonzaga University Hospital, Orbassano (Turin), Italy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Unit head
Study Record Dates
First Submitted
February 11, 2016
First Posted
March 4, 2016
Study Start
March 1, 2016
Primary Completion
March 1, 2017
Study Completion
March 1, 2017
Last Updated
March 4, 2016
Record last verified: 2016-02