--- title: PETRO Stroke Prevention in Patients With AF by Treatment With Dabigatran, With and Without Aspirin, Compared to Warfarin nct_id: NCT01227629 overall_status: COMPLETED phase: PHASE2 sponsor: Boehringer Ingelheim study_type: INTERVENTIONAL primary_condition: Atrial Fibrillation countries: United States, Denmark, Sweden canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01227629.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01227629" ct_last_update_post_date: 2014-05-05 last_seen_at: "2026-05-12T06:24:18.922Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # PETRO Stroke Prevention in Patients With AF by Treatment With Dabigatran, With and Without Aspirin, Compared to Warfarin **Official Title:** Dose Exploration in Patients With Atrial Fibrillation **NCT ID:** [NCT01227629](https://clinicaltrials.gov/study/NCT01227629) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 502 - **Lead Sponsor:** Boehringer Ingelheim - **Conditions:** Atrial Fibrillation - **Start Date:** 2003-09 - **CT.gov Last Update:** 2014-05-05 ## Brief Summary The purpose of this trial is to evaluate the safety of different doses of BIBR 1048, alone or in combination with acetylsalicylic acid (ASA), as determined by the rates of bleeding and other adverse events. A secondary objective of this trial is to evaluate the anticoagulant effect of different doses of BIBR 1048, based on the reduction of plasma concentrations of D-dimer, a laboratory marker for activated coagulation in patients with atrial fibrillation (AF), and to correlate bleeding and other events with pharmacokinetic (PK) and pharmacodynamic (PD) data. ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion criteria 1. Non-rheumatic atrial fibrillation. 2. Coronary artery disease (CAD), documented by previous myocard infarction (MI), angina, positive stress test, previous coronary intervention or bypass surgery, or atherosclerotic lesion(s) diagnosed by coronary angiography) is only considered as one of several possible qualifying risk factors. After recruitment of ca. 30%, a protocol amendment 4 was issued so that CAD was only considered as one of several possible qualifying risk factors, 2. see (3 f) below. 3. An additional risk factor for stroke, i.e. one or more of the following conditions/events: 1. hypertension (defined as systolic bloodpressure (SBP) \> 140 mmHg and/or diastolic bloodpressure (DBP) \> 90 mm Hg) requiring antihypertensive medical treatment. 2. diabetes mellitus (type I and II). 3. symptomatic heart failure or left ventricular dysfunction (ejection fraction (EF) \< 40%). 4. a previous ischemic stroke or transient ischemic attack. 5. age greater than 75 years. 6. history of coronary artery disease (by amendment 4) 4. Treatment with warfarin or other vitamin K dependent anticoagulants for at least 8 weeks prior to inclusion. International normalised ratio (INR) should be within therapeutic range (i.e. INR 2.0 - 3.0) at visit 1 otherwise the visit should be rescheduled. 5. Age \> = 18 years at entry. 6. Written, informed consent. Exclusion criteria 1. Valvular heart disease. 2. Planned cardioversion. 3. Recent (=\< 1 month) myocardial infarction, stroke or transient ischemic attack (TIA), or patients who have received a coronary stent within the last 6 months. 4. Intolerance or contraindications to acetylsalicylic acid (ASA). 5. Any contraindication to anticoagulant therapy. 6. Major bleeding within the last 6 months (other than gastrointestinal (GI) hemorrhage). 7. Severe renal impairment (estimated glomerular filtration rate (GFR) =\< 30 mL/min). 8. Uncontrolled hypertension (SBP \> 180 mmHg and/or DBP \> 100 mmHg). 9. Abnormal liver function as defined by aspartat-aminotransferase (AST), alanin-aminotransferase (ALT), serum bilirubin or alkaline phosphatase (AP) above the reference range, or history of liver disease. 10. Women who are pregnant or of childbearing potential who refuses to use a medically acceptable form of contraception throughout the study. 11. Patients who have received an investigational drug within the last 30 days. 12. Patients scheduled for major surgery or invasive procedures which may cause bleeding, or those who have had major surgery or percutaneous coronary intervention (PCI) within 6 weeks. 13. Patients considered unreliable by the investigator. 14. Another indication for anticoagulant treatment. 15. Patients suffering from anemia. 16. Patients suffering from thrombocytopenia. 17. Any other condition which, in the discretion of the investigator, would not allow safe participation in the study. 18. Concomitant treatment with antiplatelet agents other than ASA. 19. Recent malignancy or radiation therapy (=\< 6 month). ``` ## Arms - **dabigatran 50 mg twice daily (bid)** (EXPERIMENTAL) — Dabigatran: one capsule in the morning and 1 capsule in the evening. Twice daily (bis in die = bid). - **dabigatran 50 mg bid + 81 mg ASA qd** (EXPERIMENTAL) — Dabigatran: one capsule in the morning and 1 capsule in the evening. Acetylsalicylic acid (ASA) once daily (quaque dies = qd) in the morning. - **dabigatran 50 mg bid + 325 mg ASA qd** (EXPERIMENTAL) — Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning - **dabigatran 150 mg bid** (EXPERIMENTAL) — Dabigatran: one capsule in the morning and 1 capsule in the evening - **dabigatran 150 mg bid + 81 mg ASA qd** (EXPERIMENTAL) — Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning - **dabigatran 150 mg bid + 325 mg ASA qd** (EXPERIMENTAL) — Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning - **dabigatran 300 mg bid** (EXPERIMENTAL) — Dabigatran: one capsule in the morning and 1 capsule in the evening - **dabigatran 300 mg bid + 81 mg ASA qd** (EXPERIMENTAL) — Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning - **dabigatran 300 mg bid + 325 mg ASA qd** (EXPERIMENTAL) — Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning - **warfarin** (ACTIVE_COMPARATOR) — once daily, dosed to target International Normalised Ratio (INR) 2.0 to 3.0 ## Interventions - **dabigatran with ASA** (DRUG) — dose comparison in combination - **dabigatran with ASA** (DRUG) — dose comparison in combination - **dabigatran with ASA** (DRUG) — dose comparison in combination - **dabigatran with ASA** (DRUG) — dose comparison in combination - **dabigatran with ASA** (DRUG) — dose comparison in combination - **dabigatran with ASA** (DRUG) — dose comparison in combination - **warfarin** (DRUG) — comparator - **dabigatran without ASA** (DRUG) — dose comparison - **dabigatran without ASA** (DRUG) — dose comparison - **dabigatran without ASA** (DRUG) — dose comparison ## Primary Outcomes - **Number of Participants With Fatal or Life-threatening Major Bleeding Events** _(time frame: 12 weeks)_ — Retroperitoneal, intracranial, intraocular, or intraspinal bleeding, or requiring surgical treatment, or leading to a transfusion of 2 units or more, or leading to a fall in hemoglobin of 20g/L or more - **Number of Participants With Minor/Relevant Bleeding Events** _(time frame: 12 weeks)_ — Haematuria, rectal bleeding, gingival bleeding, skin hematoma of 25cm\^2 or more, nose bleed of more than 5 minutes duration, bleeding leading to a hospitalization, leading to a transfusion of less than 2 units or any other clinically relevant bleeding - **Number of Participants With Minor/Nuisance Bleeding Events** _(time frame: 12 weeks)_ — All bleeding events not fulfilling one of the criteria for major bleeding event or minor/relevant bleeding events. ## Secondary Outcomes - **Number of Participants With Thromboembolic Events: Composite Endpoint** _(time frame: 12 weeks)_ - **Number of Participants With Thromboembolic Events: Ischemic Stroke** _(time frame: 12 weeks)_ - **Thromboembolic Events: Number of Participants With Transient Ischemic Attack** _(time frame: 12 weeks)_ - **Thromboembolic Events: Number of Participants With Systemic Thromboembolism** _(time frame: 12 weeks)_ - **Thromboembolic Events: Number of Participants With Myocardial Infarction** _(time frame: 12 weeks)_ - **Thromboembolic Events: Number of Participants With Other Major Cardiac Events** _(time frame: 12 weeks)_ - **Thromboembolic Events: Number of Participants Who Died** _(time frame: 12 weeks)_ - **D-dimer: Difference From Baseline** _(time frame: baseline and 12 weeks)_ - **Soluble Fibrin: Difference From Baseline** _(time frame: baseline and 12 weeks)_ - **11-dehydrothromboxane B2 (TXB2): Difference From Baseline** _(time frame: baseline and 12 weeks)_ - **Ecarin Clotting Time (ECT): Difference From Baseline** _(time frame: baseline and 12 weeks)_ - **Activated Partial Thromboplastin Time (aPTT): Difference From Baseline** _(time frame: baseline and 12 weeks)_ - **Trough Plasma Concentration of Dabigatran (BIBR 953)** _(time frame: 12 weeks)_ - **Number of Participants With Increase of Aspartat-Aminotransferase (AST) to >2*Baseline** _(time frame: 12 weeks)_ - **Number of Participants With Increase of Alkaline Phosphatase (AP) to >2*Baseline** _(time frame: 12 weeks)_ - **Number of Participants With Increase of Bilirubin to >2*Baseline** _(time frame: 12 weeks)_ - **Number of Participants With Increase of Alanine-Aminotransferase (ALT) to >2*Baseline** _(time frame: 12 weeks)_ - **Severity of Adverse Events** _(time frame: 12 weeks)_ ## Locations (38) - 1160.20.10010, Fayetteville, Arkansas, United States - 1160.20.10003 La Mesa Cardiac, La Mesa, California, United States - 1160.20.10006 The Ford Research Institute, PA, Pensacola, Florida, United States - 1160.20.10004, Port Charlotte, Florida, United States - 1160.20.10002, St. Petersburg, Florida, United States - 1160.20.10015, Baltimore, Maryland, United States - 1160.20.10008, Westminister, Maryland, United States - 1160.20.10012, Pittsfield, Massachusetts, United States - 1160.20.10007, Troy, Michigan, United States - 1160.20.10014, Hawthorne, New York, United States - 1160.20.10013, New Hyde Park, New York, United States - 1160.20.10009, North Durham, North Carolina, United States - 1160.20.10001, Philadelphia, Pennsylvania, United States - 1160.20.10005, Germantown, Tennessee, United States - 1160.20.45010, Aalborg, Denmark - 1160.20.45005 Aarhus Sygehus, Aarhus C, Denmark - 1160.20.45007 Medicinsk afdeling, Brædstrup, Denmark - 1160.20.45003 Forskningscentret plan 3, Elsinore, Denmark - 1160.20.45011 Medicinsk afd., Esbjerg, Denmark - 1160.20.45012 Afdeling B3, Frederikssund, Denmark - 1160.20.45004 Herlev Hospital, Herlev, Denmark - 1160.20.45009 Medicinsk amb. B8, Holbæk, Denmark - 1160.20.45002 Kardiologisk afdeling, Hvidovre, Denmark - 1160.20.45014 Hjertemedicinsk afd., Køge, Denmark - 1160.20.45001 Kardiologisk Laboratorium, Odense, Denmark - 1160.20.45013 Kardiologisk afd., Roskilde, Denmark - 1160.20.45006 Medicinsk afdeling, Svendborg, Denmark - 1160.20.46013 HIA, Mälarsjukhuset, Eskilstuna, Sweden - 1160.20.46007 Falu Lasarett, Falun, Sweden - 1160.20.46005 Ryhovs Länssjukhus, Jönköping, Sweden - 1160.20.46010 Länssjukhuset Kalmar, Kalmar, Sweden - 1160.20.46009 Universitetssjukhuset MAS, Malmö, Sweden - 1160.20.46008 Vrinnevisjukhuset, Norrköping, Sweden - 1160.20.46004 Universitetssjukhuset, Örebro, Sweden - 1160.20.46002 Södersjukhuset, Stockholm, Sweden - 1160.20.46011 Arytmienheten, Med klin, Stockholm, Sweden - 1160.20.46006 Norrlands Universitetssjukhus, Umeå, Sweden - 1160.20.46003 Centrallasarettet, Västerås, Sweden ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `locations.1160.20.10014|hawthorne|new york|united states` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.1160.20.10010|fayetteville|arkansas|united states` — added _(2026-05-12)_ - `locations.1160.20.10003 la mesa cardiac|la mesa|california|united states` — added _(2026-05-12)_ - `locations.1160.20.10006 the ford research institute, pa|pensacola|florida|united states` — added _(2026-05-12)_ - `locations.1160.20.10004|port charlotte|florida|united states` — added _(2026-05-12)_ - `locations.1160.20.10002|st. petersburg|florida|united states` — added _(2026-05-12)_ - `locations.1160.20.10015|baltimore|maryland|united states` — added _(2026-05-12)_ - `locations.1160.20.10008|westminister|maryland|united states` — added _(2026-05-12)_ - `locations.1160.20.10012|pittsfield|massachusetts|united states` — added _(2026-05-12)_ - `locations.1160.20.10007|troy|michigan|united states` — added _(2026-05-12)_ - `locations.1160.20.10013|new hyde park|new york|united states` — added _(2026-05-12)_ - `locations.1160.20.10009|north durham|north carolina|united states` — added _(2026-05-12)_ - `locations.1160.20.10001|philadelphia|pennsylvania|united states` — added _(2026-05-12)_ - `locations.1160.20.10005|germantown|tennessee|united states` — added _(2026-05-12)_ - `locations.1160.20.45010|aalborg||denmark` — added _(2026-05-12)_ - `locations.1160.20.45005 aarhus sygehus|aarhus c||denmark` — added _(2026-05-12)_ - `locations.1160.20.45007 medicinsk afdeling|brædstrup||denmark` — added _(2026-05-12)_ - `locations.1160.20.45003 forskningscentret plan 3|elsinore||denmark` — added _(2026-05-12)_ - `locations.1160.20.45011 medicinsk afd.|esbjerg||denmark` — added _(2026-05-12)_ - `locations.1160.20.45012 afdeling b3|frederikssund||denmark` — added _(2026-05-12)_ - `locations.1160.20.45004 herlev hospital|herlev||denmark` — added _(2026-05-12)_ - `locations.1160.20.45009 medicinsk amb. b8|holbæk||denmark` — added _(2026-05-12)_ - `locations.1160.20.45002 kardiologisk afdeling|hvidovre||denmark` — added _(2026-05-12)_ - `locations.1160.20.45014 hjertemedicinsk afd.|køge||denmark` — added _(2026-05-12)_ - `locations.1160.20.45001 kardiologisk laboratorium|odense||denmark` — added _(2026-05-12)_ - `locations.1160.20.45013 kardiologisk afd.|roskilde||denmark` — added _(2026-05-12)_ - `locations.1160.20.45006 medicinsk afdeling|svendborg||denmark` — added _(2026-05-12)_ - `locations.1160.20.46013 hia, mälarsjukhuset|eskilstuna||sweden` — added _(2026-05-12)_ - `locations.1160.20.46007 falu lasarett|falun||sweden` — added _(2026-05-12)_ - `locations.1160.20.46005 ryhovs länssjukhus|jönköping||sweden` — added _(2026-05-12)_ - `locations.1160.20.46010 länssjukhuset kalmar|kalmar||sweden` — added _(2026-05-12)_ - `locations.1160.20.46009 universitetssjukhuset mas|malmö||sweden` — added _(2026-05-12)_ - `locations.1160.20.46008 vrinnevisjukhuset|norrköping||sweden` — added _(2026-05-12)_ - `locations.1160.20.46004 universitetssjukhuset|örebro||sweden` — added _(2026-05-12)_ - `locations.1160.20.46002 södersjukhuset|stockholm||sweden` — added _(2026-05-12)_ - `locations.1160.20.46011 arytmienheten, med klin|stockholm||sweden` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT01227629.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT01227629* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*