E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with cardiovascular risk factors undergoing elective non-cardiac surgery of high or intermediate risk. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The aim of this study is to assess the risks and benefits of continued aspirin therapy in the perioperative period. Two main questions are addressed: 1. What effect do aspirin have in reducing perioperative cardiovascular complications? 2. Is additional bleeding caused by aspirin in the perioperative period?
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E.2.2 | Secondary objectives of the trial |
Study objectives To study the effect of aspirin therapy in a high risk study population regarding: 1. Myocardial cell injury, detected by Troponin T. 2. Myocardial infarction, diagnosed in accordance to the European Society of Cardiology`s and American College of Cardiology`s published guidelines. 3. Thrombotic cerebrovascular accident 4. Long-term outcome, i.e. mortality one year after surgery. 5. Complications, including: a. Incisional hemorrhagic complication b. Gastrointestinal bleeding c. Hemorrhagic cerebrovascular accident d. Spinal/Epidural hematoma 6. Prediction of perioperative myocardial injury and/or poor long-term prognosis by BNP (brain natriuretic peptide), CRP and albumin.
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
ASA resistance in non-cardiac surgery. Date 20070601, version 1 To assess the incidence of Aspriron resistance in 100 consecutive patients, included in ASINC at Lunkoping University Hospital. Objectives: To study the effect of placebo/aspirin on thrombocyte function, by thrombocyte aggregationstests, Urine-Tromboxan B2. To correlate the incidence of aspirin resistance to myocardial injury, ischemia and infarction in the perioperative period. To assess the effect of surgical trauma on thrombocyte function in placebo/aspirin treated patients. |
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E.3 | Principal inclusion criteria |
Patients with at least one of the following risk factors will be included:
· Patients with known or suspected ischemic heart disease · Medical history of congestive heart failure · Renal impairment (S-creatinine > 170 µmol·ml-1). · History of cerebrovascular accident · Insulin treated Diabetes Mellitus.
To be included the patient must undergo surgical procedures of high or intermediate risk. In this study patients undergoing the following procedures will be possible to include:· Laparatomier med förväntad operationstid > 1 timme inkluderande: · Esofagus kirurgi · Pancreas kirurgi · Ventrikel kirurgi · Lever kirurgi · Gallvägskirurgi (ej okomplcerade cholecystektomier) · Intraabdominell endokrin kirurgi · Tarm kirurgi · Fundoplicatio/Crusplastik
Urologisk kirurgi inkluderande: · Prostata kirurgi, bade open samt transuretral · Nefrektomi · Cystektomi
Ortopedisk protes kirurgi, inkluderande: · Höft artroplastik · Knä artroplastik · Axel artroplastik
Gynekologisk kirurgi, inkluderande · Abdominell hysterektomi · Transabdominell gynonkologisk kirurgi
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E.4 | Principal exclusion criteria |
Exclusion criteria · Patients undergoing diagnostic procedures · Patients with unstable CAD · Patients with incompensated congestive heart failure · Patients in shock. · Patients with pacemaker. · Patients under 18 years. · Patients with an allergy to aspirin · Patients with a known history of ulcer · Patients on Warfarin or Clopidogrel
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E.5 End points |
E.5.1 | Primary end point(s) |
5. Study outcome 5.1 Primary outcome A. Perioperative myocardial injury B. Perioperative myocardial infarction C. Incidence of haemorrhagic complications.
Other outcomes A. One year mortality Cardiac events (myocardial infarction, PCI and/or CABG,) and thrombotic cerebrovascular events within one year after surgery. Correlation between perioperative myocardial injury and preoperative albumin, CRP, BNP and TnT. B. Correlation between postoperative TnT and long-term prognosis. Risk of perioperative myocardial injury related to aspirin treatment compared to placebo. C. Risk of death one year after surgery related to aspirin treatment compared to placebo.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of trial: One year after inclusion of the 660 patient.That is when the one year follow up period is complteted for all included patients. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |